FDA Medical Device Recalls

🩺 Search FDA medical device recalls for compliance review

Search public U.S. FDA medical-device recalls with one device, product, or recall-reason phrase. FDA Medical Device Recalls saves structured recall evidence with identifiers, product and firm details, classes, statuses, lifecycle dates, risk context, and official FDA source links. It helps compliance, hospital, procurement, and safety teams review a focused dataset and decide what needs a closer look.

Use it to:

• Find a focused set for a dated review with FDA recall list 2026.
• Compare grouped counts by FDA class with FDA recall classification when you need a severity breakdown.
• Review structured rows and FDA source links with FDA recall database for a device phrase.
• Narrow matching records by firm, status, area, or date with FDA recall list.
• Compare new and unchanged matches across runs with FDA recalls when Track changes is enabled.

📋 FDA recall rows with source evidence

Each saved dataset row represents one matching public U.S. FDA medical-device recall. Rows keep recall identifiers, product and firm details, FDA class and status, lifecycle dates, recall reasons, distribution areas, risk context, coverage details, and an official FDA source link. Optional fields add grouped counts, inventory review context, manufacturer history, trend context, adverse-event context, and watchlist comparison data.

An inventory match is a review signal, not proof that a particular model, lot, serial number, or patient is affected. Recall evidence also does not prove causation, patient harm, recall completion, or the absence of other recalls. Check the linked FDA source before making medical, legal, regulatory, or safety decisions.

▶️ Run a focused device recall search

1. Enter one device, product, or recall-reason phrase in Search phrase. Run a separate search for another phrase.
2. Add optional firm, class, status, distribution, and date filters when you need a narrower result set.
3. Set Maximum recalls when you want a limit. Leave it empty to return all available results until the FDA source is exhausted.
4. Add device inventory when you want potential matches for review. Enable Track changes to compare the same search settings with earlier runs.
5. Start the run and open the default dataset. Use the source link and evidence limits in each row for follow-up.

⚙️ Input

Input fields

Field	Type	What it does
searchQuery	string, required	Enter one device, product, or recall-reason phrase. Run a separate search for another phrase.
recallingFirms	array of strings	Enter one or more recalling firms to filter the results.
recallClasses	array of strings	Choose one or more FDA recall classes. Leave empty to include all classes.
recallStatuses	array of strings	Choose one or more recall statuses. Leave empty to include all statuses.
distributionAreas	array of strings	Enter one or more states, regions, or distribution terms to filter by geography.
startDate	string, YYYY-MM-DD	Include recalls on or after this calendar date.
endDate	string, YYYY-MM-DD	Include recalls on or before this calendar date.
maxItems	integer	Stop after this many matching recalls. If you leave it blank, the Actor continues until the FDA source is exhausted.
groupBy	string	Choose one dimension for counts, ranks, and shares. Leave blank for no grouped breakdown.
deviceInventory	array of objects	Add devices to compare with matching recalls. A match is a review signal, not proof that an item is affected.
deviceInventory.deviceName	string, required in each item	Name or product description for the inventory item.
deviceInventory.manufacturer	string	Manufacturer name, if known.
deviceInventory.model	string	Model or catalog model, if known.
deviceInventory.catalogNumber	string	Catalog or product number, if known.
deviceInventory.lotNumber	string	Lot or batch number, if known.
deviceInventory.serialNumber	string	Serial number, if known.
trackChanges	boolean	Compare this search with earlier runs that use the same search settings and report new or unchanged records with prior status, class, and risk context.

Default input

This example is copied from a successful default-input run:

{
  "searchQuery": "insulin pump",
  "maxItems": 25
}

🧾 Output

The default dataset stores one recall-row shape. Optional fields appear when the source or selected inputs provide that context. Fields that the FDA source does not provide can be absent. The table covers every public output field.

Recall row fields

Field	Type	What it does
recallNumber	string	FDA recall number for the record.
product	object	Holds device or product details.
product.description	string	Describes the device or product in the FDA record.
product.type	string	Shows the product type reported by FDA.
product.brandName	string	Shows the reported brand name, when available.
product.model	string	Shows the reported model or catalog model, when available.
product.catalogNumber	string	Shows the reported catalog or product number, when available.
productCodes	array of objects	Lists FDA product codes linked to the product.
productCodes[].code	string	Gives the FDA product code.
productCodes[].name	string	Gives the product code name.
productCodes[].specialty	string	Gives the linked medical specialty.
recallingFirm	object	Holds details about the firm named in the recall.
recallingFirm.name	string	Gives the recalling firm name.
recallingFirm.city	string	Gives the firm's city.
recallingFirm.state	string	Gives the firm's state or region.
recallingFirm.country	string	Gives the firm's country.
recallClass	string	Gives the FDA recall class.
recallStatus	string	Gives the FDA recall status.
lifecycleDates	object	Holds important dates in the recall lifecycle.
lifecycleDates.initiationDate	date string	Gives the date the recall was initiated.
lifecycleDates.reportDate	date string	Gives the date the recall was reported to FDA.
lifecycleDates.classificationDate	date string	Gives the date FDA assigned the recall class.
lifecycleDates.terminationDate	date string	Gives the termination date, when reported.
recallReason	string	Gives the reason for the recall.
distributionAreas	array of strings	Lists reported distribution areas.
quantity	number	Gives the normalized number of units reported for the recall.
quantityUnit	string	Gives the unit used for the reported quantity.
notificationMethod	string	Gives the initial firm notification method.
recallAction	string	Says whether the recall was voluntary or mandated.
risk	object	Holds the risk assessment.
risk.score	number	Gives the normalized risk score.
risk.tier	string	Gives the assigned risk tier.
risk.recommendedActions	array of strings	Lists review actions suggested by the risk triage.
activity	string	Gives the normalized active or inactive state.
failureModes	array of strings	Lists failure modes identified in the recall evidence.
repeatIssue	boolean	Says whether the manufacturer history shows a related repeat issue.
attention	object	Holds review attention context.
attention.level	string	Gives the suggested review attention level.
attention.reasons	array of strings	Lists reasons for the attention level.
inventoryExposure	object	Holds potential inventory matches for review. A match is not proof that an item is affected.
inventoryExposure.matchedItems	array of objects	Lists submitted inventory items with potential matches.
inventoryExposure.matchedItems[].deviceName	string	Gives the submitted inventory item name.
inventoryExposure.matchedItems[].matchedOn	array of strings	Lists inventory fields that supported the potential match.
inventoryExposure.matchedItems[].reviewPriority	string	Gives the review priority for the potential match.
inventoryExposure.matchedItems[].reviewReason	string	Explains why the inventory item needs review.
inventoryExposure.reviewQueueRank	integer	Gives the position in the potential-match review queue.
coverage	object	Holds search coverage details.
coverage.matchedCount	integer	Gives the number of matching records found in the available FDA result set.
coverage.returnedCount	integer	Gives the number of recall records returned in the run.
coverage.isTruncated	boolean	Says whether the returned records are bounded by the source or run limit.
coverage.limit	integer	Gives the run limit when one was set.
coverage.disclosure	string	Explains the available result coverage.
summary	object	Holds counts and breakdowns for successful recall rows in the run.
summary.byRecallClass	array of objects	Counts and ranks rows by FDA recall class.
summary.byRecallClass[].value	string	Gives the recall class in the summary.
summary.byRecallClass[].count	integer	Gives the number of rows in the class.
summary.byRecallClass[].rank	integer	Gives the class rank by row count.
summary.byRecallClass[].share	number	Gives the class share of returned rows.
summary.byRecallStatus	array of objects	Counts and ranks rows by recall status.
summary.byRecallStatus[].value	string	Gives the recall status in the summary.
summary.byRecallStatus[].count	integer	Gives the number of rows with the status.
summary.byRecallStatus[].rank	integer	Gives the status rank by row count.
summary.byRecallStatus[].share	number	Gives the status share of returned rows.
summary.byRiskTier	array of objects	Counts and ranks rows by risk tier.
summary.byRiskTier[].value	string	Gives the risk tier in the summary.
summary.byRiskTier[].count	integer	Gives the number of rows in the tier.
summary.byRiskTier[].rank	integer	Gives the tier rank by row count.
summary.byRiskTier[].share	number	Gives the tier share of returned rows.
summary.byActivity	array of objects	Counts and ranks rows by activity state.
summary.byActivity[].value	string	Gives the activity state in the summary.
summary.byActivity[].count	integer	Gives the number of rows in the state.
summary.byActivity[].rank	integer	Gives the state rank by row count.
summary.byActivity[].share	number	Gives the state share of returned rows.
summary.byFailureMode	array of objects	Counts and ranks rows by failure mode.
summary.byFailureMode[].value	string	Gives the failure mode in the summary.
summary.byFailureMode[].count	integer	Gives the number of rows with the failure mode.
summary.byFailureMode[].rank	integer	Gives the failure-mode rank by row count.
summary.byFailureMode[].share	number	Gives the failure-mode share of returned rows.
summary.byRecallingFirm	array of objects	Counts and ranks rows by recalling firm.
summary.byRecallingFirm[].value	string	Gives the firm in the summary.
summary.byRecallingFirm[].count	integer	Gives the number of rows for the firm.
summary.byRecallingFirm[].rank	integer	Gives the firm rank by row count.
summary.byRecallingFirm[].share	number	Gives the firm's share of returned rows.
groupedAnalysis	object	Holds the selected group dimension, value, count, rank, and share.
groupedAnalysis.dimension	string	Gives the dimension selected with groupBy.
groupedAnalysis.value	string	Gives the value of the selected dimension.
groupedAnalysis.count	integer	Gives the number of rows in the group.
groupedAnalysis.rank	integer	Gives the group rank by row count.
groupedAnalysis.share	number	Gives the group's share of returned rows.
manufacturerProfile	object	Holds related recall history and supplier risk signals for the firm.
manufacturerProfile.recallHistory	array of objects	Lists related recall records for the firm.
manufacturerProfile.recallHistory[].recallNumber	string	Gives a related FDA recall number.
manufacturerProfile.recallHistory[].recallClass	string	Gives the related recall class.
manufacturerProfile.recallHistory[].recallStatus	string	Gives the related recall status.
manufacturerProfile.recallHistory[].initiationDate	date string	Gives the related recall initiation date.
manufacturerProfile.recallHistory[].sourceUrl	URL string	Links to the related FDA source.
manufacturerProfile.supplierRiskSignals	array of strings	Lists supplier risk signals from the firm's recall history.
trend	object	Compares recent recall activity with an earlier period.
trend.currentPeriod	object	Holds the recent comparison period.
trend.currentPeriod.startDate	date string	Gives the recent period start date.
trend.currentPeriod.endDate	date string	Gives the recent period end date.
trend.currentPeriod.recallCount	integer	Gives the recent period recall count.
trend.previousPeriod	object	Holds the earlier comparison period.
trend.previousPeriod.startDate	date string	Gives the earlier period start date.
trend.previousPeriod.endDate	date string	Gives the earlier period end date.
trend.previousPeriod.recallCount	integer	Gives the earlier period recall count.
trend.direction	string	Gives the direction of recall activity compared with the earlier period.
adverseEventContext	object	Holds clearly labeled manufacturer-level adverse-event trend context and its limits.
adverseEventContext.periodStart	date string	Gives the adverse-event context period start.
adverseEventContext.periodEnd	date string	Gives the adverse-event context period end.
adverseEventContext.eventCount	integer	Gives the manufacturer-level event count in the period.
adverseEventContext.trend	string	Gives the direction of the manufacturer-level event trend.
adverseEventContext.limitations	array of strings	Lists limits on how the context should be read.
watchlist	object	Holds comparison data from an earlier baseline when Track changes is enabled.
watchlist.changeType	string	Says whether the record is new or unchanged since the earlier baseline.
watchlist.previousStatus	string	Gives the earlier recorded recall status, when available.
watchlist.previousClass	string	Gives the earlier recorded FDA recall class, when available.
watchlist.previousRiskTier	string	Gives the earlier recorded risk tier, when available.
sourceUrl	URL string	Links to the official FDA source for the recall.
evidenceLimitations	array of strings	Lists limits on what the recall evidence can show.

The examples below are genuine rows from successful runs and use two-space indentation. The grouped, inventory, and watchlist examples shorten large nested data and show omitted values as the JSON string "...". Their other shown keys, values, arrays, objects, and order are preserved.

Recall record example

{
  "recallNumber": "Z-1594-2020",
  "product": {
    "description": "Medtronic  MiniMed Paradigm Insulin pump, model number MMT-723",
    "type": "Devices",
    "brandName": "PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP",
    "model": "MMT-723",
    "catalogNumber": "MMT-723"
  },
  "recallingFirm": {
    "name": "Medtronic MiniMed",
    "city": "Northridge",
    "state": "CA",
    "country": "United States"
  },
  "recallClass": "Class II",
  "recallStatus": "Ongoing",
  "lifecycleDates": {
    "initiationDate": "2019-06-27",
    "reportDate": "2020-04-01",
    "classificationDate": "2020-03-26"
  },
  "recallReason": "The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.",
  "productCodes": [
    {
      "code": "OYC",
      "name": "Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor",
      "specialty": "Unknown"
    }
  ],
  "distributionAreas": [
    "US nationwide distribution including Puerto Rico."
  ],
  "notificationMethod": "Letter",
  "recallAction": "Voluntary",
  "risk": {
    "score": 55,
    "tier": "Moderate",
    "recommendedActions": [
      "Review the FDA Class II classification",
      "Review the source reason: The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF)"
    ]
  },
  "attention": {
    "level": "Review",
    "reasons": [
      "FDA Class II classification.",
      "Recall status is Ongoing."
    ]
  },
  "activity": "Active",
  "failureModes": [
    "The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF)"
  ],
  "coverage": {
    "matchedCount": 5,
    "returnedCount": 1,
    "isTruncated": true,
    "disclosure": "FDA returned 1 of 5 matching records for this run."
  },
  "summary": {
    "byRecallClass": [
      {
        "value": "Class II",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byRecallStatus": [
      {
        "value": "Ongoing",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byRiskTier": [
      {
        "value": "Moderate",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byActivity": [
      {
        "value": "Active",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byFailureMode": [
      {
        "value": "The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF)",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byRecallingFirm": [
      {
        "value": "Medtronic MiniMed",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ]
  },
  "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433",
  "evidenceLimitations": [
    "Recall evidence comes from official U.S. FDA OpenFDA records.",
    "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "https://open.fda.gov/terms/"
  ],
  "manufacturerProfile": {
    "recallHistory": [
      {
        "recallNumber": "Z-1594-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-0033-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2025-05-07",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=96745"
      },
      {
        "recallNumber": "Z-1592-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-1745-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-0524-2015",
        "recallClass": "Class II",
        "recallStatus": "Terminated",
        "initiationDate": "2014-11-04",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=69720"
      },
      {
        "recallNumber": "Z-1749-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-1650-2025",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2025-03-04",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=96421"
      },
      {
        "recallNumber": "Z-1752-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-1228-2015",
        "recallClass": "Class III",
        "recallStatus": "Terminated",
        "initiationDate": "2014-11-10",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=70424"
      },
      {
        "recallNumber": "Z-1265-2025",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2025-01-31",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=96200"
      },
      {
        "recallNumber": "Z-1747-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-0002-2025",
        "recallClass": "Class I",
        "recallStatus": "Ongoing",
        "initiationDate": "2024-07-31",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95121"
      },
      {
        "recallNumber": "Z-1586-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-2778-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-06-16",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99228"
      },
      {
        "recallNumber": "Z-1748-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-1581-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-2179-2014",
        "recallClass": "Class II",
        "recallStatus": "Terminated",
        "initiationDate": "2014-07-21",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=68888"
      },
      {
        "recallNumber": "Z-1587-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-1354-2022",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2022-05-23",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=90370"
      },
      {
        "recallNumber": "Z-1085-2013",
        "recallClass": "Class II",
        "recallStatus": "Terminated",
        "initiationDate": "2013-03-22",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=64754"
      }
    ],
    "supplierRiskSignals": [
      "85 related FDA recall records were found for this firm.",
      "16 related records remain ongoing."
    ]
  },
  "repeatIssue": true,
  "trend": {
    "previousPeriod": {
      "startDate": "2020-01-01",
      "endDate": "2021-12-31",
      "recallCount": 0
    },
    "currentPeriod": {
      "startDate": "2022-01-01",
      "endDate": "2026-12-31",
      "recallCount": 2
    },
    "direction": "Increasing"
  },
  "adverseEventContext": {
    "periodStart": "2023-01-01",
    "periodEnd": "2026-12-31",
    "eventCount": 215405,
    "trend": "Increasing",
    "limitations": [
      "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
      "https://open.fda.gov/terms/",
      "Manufacturer-level adverse-event context does not show causation or patient harm."
    ]
  }
}

Grouped analysis example

{
  "recallNumber": "Z-2113-2018",
  "product": {
    "description": "Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2    Product Usage:  The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physician\u0019s directive.",
    "type": "Devices"
  },
  "recallingFirm": {
    "name": "Baxter Healthcare Corporation",
    "city": "Medina",
    "state": "NY",
    "country": "United States"
  },
  "recallClass": "Class II",
  "recallStatus": "Terminated",
  "lifecycleDates": {
    "initiationDate": "2018-05-08",
    "reportDate": "2018-06-13",
    "classificationDate": "2018-06-07",
    "terminationDate": "2019-04-08"
  },
  "recallReason": "The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary infusion. However, the firm supplies 12.5-inch hangers with the Baxter disposable secondary sets.",
  "distributionAreas": [
    "Worldwide Distribution - US Nationwide and the country of  Canada."
  ],
  "notificationMethod": "Letter",
  "recallAction": "Voluntary",
  "risk": {
    "score": 45,
    "tier": "Moderate",
    "recommendedActions": [
      "Review the FDA Class II classification",
      "Review the source reason: The firm will be updating the Instructions for Use for the product"
    ]
  },
  "attention": {
    "level": "Review",
    "reasons": [
      "FDA Class II classification.",
      "Recall status is Terminated."
    ]
  },
  "activity": "Inactive",
  "failureModes": [
    "The firm will be updating the Instructions for Use for the product"
  ],
  "coverage": {
    "matchedCount": 734,
    "returnedCount": 1,
    "isTruncated": true,
    "limit": 1,
    "disclosure": "FDA returned 1 of 734 matching records for this run with a limit of 1."
  },
  "summary": {
    "byRecallClass": [
      {
        "value": "Class II",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byRecallStatus": [
      {
        "value": "Terminated",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byRiskTier": [
      {
        "value": "Moderate",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byActivity": [
      {
        "value": "Inactive",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byFailureMode": [
      {
        "value": "The firm will be updating the Instructions for Use for the product",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byRecallingFirm": [
      {
        "value": "Baxter Healthcare Corporation",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ]
  },
  "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=80014",
  "evidenceLimitations": "...",
  "groupedAnalysis": {
    "dimension": "failureMode",
    "value": "The firm will be updating the Instructions for Use for the product",
    "count": 1,
    "rank": 1,
    "share": 1
  },
  "manufacturerProfile": {
    "recallHistory": [
      {
        "recallNumber": "Z-2113-2018",
        "recallClass": "Class II",
        "recallStatus": "Terminated",
        "initiationDate": "2018-05-08",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=80014"
      },
      {
        "recallNumber": "Z-0190-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2025-08-29",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97604"
      },
      {
        "recallNumber": "Z-0560-2025",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2024-10-23",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95524"
      },
      {
        "recallNumber": "Z-0884-2025",
        "recallClass": "Class I",
        "recallStatus": "Ongoing",
        "initiationDate": "2024-12-20",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95842"
      },
      {
        "recallNumber": "Z-1926-2018",
        "recallClass": "Class II",
        "recallStatus": "Terminated",
        "initiationDate": "2018-04-24",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=79965"
      },
      {
        "recallNumber": "Z-0762-2023",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2022-11-23",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=91223"
      },
      {
        "recallNumber": "Z-0559-2025",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2024-10-23",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95524"
      },
      {
        "recallNumber": "Z-3085-2024",
        "recallClass": "Class I",
        "recallStatus": "Ongoing",
        "initiationDate": "2024-08-20",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95192"
      },
      {
        "recallNumber": "Z-0276-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-10-04",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83852"
      },
      {
        "recallNumber": "Z-0576-2022",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2022-01-07",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=89327"
      },
      {
        "recallNumber": "Z-1689-2024",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2024-03-15",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=94298"
      },
      {
        "recallNumber": "Z-1578-2022",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2022-07-22",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=90658"
      },
      {
        "recallNumber": "Z-0216-2025",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2024-09-19",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95409"
      },
      {
        "recallNumber": "Z-0572-2022",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2022-01-07",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=89327"
      },
      {
        "recallNumber": "Z-0323-2025",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2024-10-11",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95559"
      },
      {
        "recallNumber": "Z-0030-2020",
        "recallClass": "Class II",
        "recallStatus": "Terminated",
        "initiationDate": "2018-10-10",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83191"
      },
      {
        "recallNumber": "Z-1909-2019",
        "recallClass": "Class II",
        "recallStatus": "Terminated",
        "initiationDate": "2019-05-31",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83015"
      },
      {
        "recallNumber": "Z-0663-2024",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2023-12-06",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93503"
      },
      {
        "recallNumber": "Z-1817-2022",
        "recallClass": "Class III",
        "recallStatus": "Ongoing",
        "initiationDate": "2022-09-02",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=90809"
      },
      {
        "recallNumber": "Z-1909-2018",
        "recallClass": "Class II",
        "recallStatus": "Terminated",
        "initiationDate": "2018-04-25",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=79975"
      }
    ],
    "supplierRiskSignals": [
      "378 related FDA recall records were found for this firm.",
      "15 related records remain ongoing."
    ]
  },
  "repeatIssue": true,
  "trend": {
    "previousPeriod": {
      "startDate": "2020-01-01",
      "endDate": "2021-12-31",
      "recallCount": 133
    },
    "currentPeriod": {
      "startDate": "2022-01-01",
      "endDate": "2026-12-31",
      "recallCount": 11
    },
    "direction": "Decreasing"
  },
  "adverseEventContext": "..."
}

Inventory review example

{
  "recallNumber": "Z-1594-2020",
  "product": {
    "description": "Medtronic  MiniMed Paradigm Insulin pump, model number MMT-723",
    "type": "Devices",
    "brandName": "PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP",
    "model": "MMT-723",
    "catalogNumber": "MMT-723"
  },
  "recallingFirm": {
    "name": "Medtronic MiniMed",
    "city": "Northridge",
    "state": "CA",
    "country": "United States"
  },
  "recallClass": "Class II",
  "recallStatus": "Ongoing",
  "lifecycleDates": {
    "initiationDate": "2019-06-27",
    "reportDate": "2020-04-01",
    "classificationDate": "2020-03-26"
  },
  "recallReason": "The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.",
  "productCodes": [
    {
      "code": "OYC",
      "name": "Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor",
      "specialty": "Unknown"
    }
  ],
  "distributionAreas": [
    "US nationwide distribution including Puerto Rico."
  ],
  "notificationMethod": "Letter",
  "recallAction": "Voluntary",
  "risk": {
    "score": 55,
    "tier": "Moderate",
    "recommendedActions": [
      "Review the FDA Class II classification",
      "Review the source reason: The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF)"
    ]
  },
  "attention": {
    "level": "Review",
    "reasons": [
      "FDA Class II classification.",
      "Recall status is Ongoing."
    ]
  },
  "activity": "Active",
  "failureModes": [
    "The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF)"
  ],
  "coverage": {
    "matchedCount": 95,
    "returnedCount": 1,
    "isTruncated": true,
    "limit": 1,
    "disclosure": "FDA returned 1 of 95 matching records for this run with a limit of 1."
  },
  "summary": {
    "byRecallClass": [
      {
        "value": "Class II",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byRecallStatus": [
      {
        "value": "Ongoing",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byRiskTier": [
      {
        "value": "Moderate",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byActivity": [
      {
        "value": "Active",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byFailureMode": [
      {
        "value": "The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF)",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byRecallingFirm": [
      {
        "value": "Medtronic MiniMed",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ]
  },
  "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433",
  "evidenceLimitations": [
    "Recall evidence comes from official U.S. FDA OpenFDA records.",
    "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "https://open.fda.gov/terms/"
  ],
  "inventoryExposure": {
    "matchedItems": [
      {
        "deviceName": "Medtronic MiniMed",
        "matchedOn": [
          "deviceName"
        ],
        "reviewPriority": "Low",
        "reviewReason": "Potential source match on deviceName; review is not proof that an item is affected."
      }
    ],
    "reviewQueueRank": 1
  },
  "manufacturerProfile": {
    "recallHistory": [
      {
        "recallNumber": "Z-1594-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-0033-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2025-05-07",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=96745"
      },
      {
        "recallNumber": "Z-1592-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-1745-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-0524-2015",
        "recallClass": "Class II",
        "recallStatus": "Terminated",
        "initiationDate": "2014-11-04",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=69720"
      },
      {
        "recallNumber": "Z-1749-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-1650-2025",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2025-03-04",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=96421"
      },
      {
        "recallNumber": "Z-1752-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-1228-2015",
        "recallClass": "Class III",
        "recallStatus": "Terminated",
        "initiationDate": "2014-11-10",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=70424"
      },
      {
        "recallNumber": "Z-1265-2025",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2025-01-31",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=96200"
      },
      {
        "recallNumber": "Z-1747-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-0002-2025",
        "recallClass": "Class I",
        "recallStatus": "Ongoing",
        "initiationDate": "2024-07-31",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95121"
      },
      {
        "recallNumber": "Z-1586-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-2778-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-06-16",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99228"
      },
      {
        "recallNumber": "Z-1748-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-1581-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-2179-2014",
        "recallClass": "Class II",
        "recallStatus": "Terminated",
        "initiationDate": "2014-07-21",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=68888"
      },
      {
        "recallNumber": "Z-1587-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-1354-2022",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2022-05-23",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=90370"
      },
      {
        "recallNumber": "Z-1085-2013",
        "recallClass": "Class II",
        "recallStatus": "Terminated",
        "initiationDate": "2013-03-22",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=64754"
      }
    ],
    "supplierRiskSignals": [
      "85 related FDA recall records were found for this firm.",
      "16 related records remain ongoing."
    ]
  },
  "repeatIssue": true,
  "trend": {
    "previousPeriod": {
      "startDate": "2020-01-01",
      "endDate": "2021-12-31",
      "recallCount": 8
    },
    "currentPeriod": {
      "startDate": "2022-01-01",
      "endDate": "2026-12-31",
      "recallCount": 55
    },
    "direction": "Increasing"
  },
  "adverseEventContext": "..."
}

Watchlist comparison example

{
  "recallNumber": "Z-1594-2020",
  "product": {
    "description": "Medtronic  MiniMed Paradigm Insulin pump, model number MMT-723",
    "type": "Devices",
    "brandName": "PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP",
    "model": "MMT-723",
    "catalogNumber": "MMT-723"
  },
  "recallingFirm": {
    "name": "Medtronic MiniMed",
    "city": "Northridge",
    "state": "CA",
    "country": "United States"
  },
  "recallClass": "Class II",
  "recallStatus": "Ongoing",
  "lifecycleDates": {
    "initiationDate": "2019-06-27",
    "reportDate": "2020-04-01",
    "classificationDate": "2020-03-26"
  },
  "recallReason": "The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.",
  "productCodes": [
    {
      "code": "OYC",
      "name": "Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor",
      "specialty": "Unknown"
    }
  ],
  "distributionAreas": [
    "US nationwide distribution including Puerto Rico."
  ],
  "notificationMethod": "Letter",
  "recallAction": "Voluntary",
  "risk": {
    "score": 55,
    "tier": "Moderate",
    "recommendedActions": [
      "Review the FDA Class II classification",
      "Review the source reason: The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF)"
    ]
  },
  "attention": {
    "level": "Review",
    "reasons": [
      "FDA Class II classification.",
      "Recall status is Ongoing."
    ]
  },
  "activity": "Active",
  "failureModes": [
    "The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF)"
  ],
  "coverage": {
    "matchedCount": 5,
    "returnedCount": 1,
    "isTruncated": true,
    "limit": 1,
    "disclosure": "FDA returned 1 of 5 matching records for this run with a limit of 1."
  },
  "summary": {
    "byRecallClass": [
      {
        "value": "Class II",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byRecallStatus": [
      {
        "value": "Ongoing",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byRiskTier": [
      {
        "value": "Moderate",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byActivity": [
      {
        "value": "Active",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byFailureMode": [
      {
        "value": "The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF)",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ],
    "byRecallingFirm": [
      {
        "value": "Medtronic MiniMed",
        "count": 1,
        "rank": 1,
        "share": 1
      }
    ]
  },
  "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433",
  "evidenceLimitations": [
    "Recall evidence comes from official U.S. FDA OpenFDA records.",
    "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "https://open.fda.gov/terms/"
  ],
  "manufacturerProfile": {
    "recallHistory": [
      {
        "recallNumber": "Z-1594-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-0033-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2025-05-07",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=96745"
      },
      {
        "recallNumber": "Z-1592-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-1745-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-0524-2015",
        "recallClass": "Class II",
        "recallStatus": "Terminated",
        "initiationDate": "2014-11-04",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=69720"
      },
      {
        "recallNumber": "Z-1749-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-1650-2025",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2025-03-04",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=96421"
      },
      {
        "recallNumber": "Z-1752-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-1228-2015",
        "recallClass": "Class III",
        "recallStatus": "Terminated",
        "initiationDate": "2014-11-10",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=70424"
      },
      {
        "recallNumber": "Z-1265-2025",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2025-01-31",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=96200"
      },
      {
        "recallNumber": "Z-1747-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-0002-2025",
        "recallClass": "Class I",
        "recallStatus": "Ongoing",
        "initiationDate": "2024-07-31",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95121"
      },
      {
        "recallNumber": "Z-1586-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-2778-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-06-16",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99228"
      },
      {
        "recallNumber": "Z-1748-2026",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2026-02-13",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98186"
      },
      {
        "recallNumber": "Z-1581-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-2179-2014",
        "recallClass": "Class II",
        "recallStatus": "Terminated",
        "initiationDate": "2014-07-21",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=68888"
      },
      {
        "recallNumber": "Z-1587-2020",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2019-06-27",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=83433"
      },
      {
        "recallNumber": "Z-1354-2022",
        "recallClass": "Class II",
        "recallStatus": "Ongoing",
        "initiationDate": "2022-05-23",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=90370"
      },
      {
        "recallNumber": "Z-1085-2013",
        "recallClass": "Class II",
        "recallStatus": "Terminated",
        "initiationDate": "2013-03-22",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=64754"
      }
    ],
    "supplierRiskSignals": [
      "85 related FDA recall records were found for this firm.",
      "16 related records remain ongoing."
    ]
  },
  "repeatIssue": true,
  "trend": {
    "previousPeriod": {
      "startDate": "2020-01-01",
      "endDate": "2021-12-31",
      "recallCount": 0
    },
    "currentPeriod": {
      "startDate": "2022-01-01",
      "endDate": "2026-12-31",
      "recallCount": 2
    },
    "direction": "Increasing"
  },
  "adverseEventContext": "...",
  "watchlist": {
    "changeType": "Unchanged",
    "previousStatus": "Ongoing",
    "previousClass": "Class II",
    "previousRiskTier": "Moderate"
  }
}

💳 Pricing

The Actor charges $0.0018 for each matching medical-device recall record returned with structured recall evidence. The event is tied to a saved recall, not to a vague result count.

🔌 Integrations

Open the default dataset in Apify Console, export its records, or use the dataset API link in a downstream workflow. Repeat the same search with Track changes enabled when you want to compare later runs.

❓ FAQ

Does an inventory match prove that my device is affected?

No. It is a potential match for review. Check the FDA source record and the model, catalog, lot, or serial details before making a safety or medical decision.

What does Track changes report?

It compares the search with an earlier run that uses the same search settings and reports records as new or unchanged with earlier status, class, and risk context when available.

What happens when I leave Maximum recalls empty?

The Actor returns all available matching results until the FDA source is exhausted. Set a value when you want the run to stop after a chosen number of recalls.

Can one run perform several independent searches?

No. Enter one search phrase per run. Start another run when you need a separate phrase or search setup.

How should I read the risk score and recommended actions?

They are review context produced from the recall evidence. They do not prove causation, patient harm, recall completion, or that a particular device is affected.

Can I group the returned recalls?

Yes. Choose one Group results by dimension. Each grouped row can include the selected dimension, value, count, rank, and share in groupedAnalysis.

What does the FDA source link provide?

It links to the public FDA source used for the recall row. Use it to verify important product, lifecycle, and recall details.

Does this Actor give medical, legal, or regulatory advice?

No. It returns public recall evidence and review context. Qualified professionals and the FDA source should guide those decisions.

📝 Changelog

v0.0 (27-09-2026)

• Initial release.

🆘 Support

For issues, questions, or feature requests, file a ticket and I'll fix or implement it in less than 24h 🫡

🔗 Related Actors

• FDA Food Recall Monitor: search official FDA food-enforcement recalls alongside device recalls.
• FDA 510(k) Device Clearance Search: review pre-market FDA device clearance records before post-market recall research.
• FDA FAERS Adverse Events: review public FDA adverse-event reports alongside device recall evidence.
• FDA Import Alert Monitor: check FDA import-alert findings during product and supplier compliance review.
• CPSC Product Recalls Scraper: search official consumer-product recalls for broader safety review.

Made with ❤️ by Maxime Dupré