openFDA Drug, Device & Biologics Recall Scraper (USA)

Here is one real result, with every field the actor returns (the distributionPattern is trimmed here for length; AI add-on fields included):

{
  "source": "enforcement",
  "endpoint": "/device/enforcement.json",
  "recallNumber": "Z-2372-2023",
  "status": "Ongoing",
  "classification": "Class I",
  "productType": "Devices",
  "productDescription": "MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray    REF: 8888102004HP",
  "reasonForRecall": "Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded catheter may lead to full obstruction resulting in delay to treatment, hemolysis, embolism or thrombosis.",
  "recallingFirm": "Covidien LP",
  "city": "Mansfield",
  "state": "MA",
  "country": "United States",
  "postalCode": "02048-1113",
  "addressLine1": "15 Hampshire St",
  "addressLine2": null,
  "distributionPattern": "US Nationwide - Worldwide Distribution. Foreign: Argentina Austria Bahrain Bangladesh Belgium Brazil Canada China ...",
  "productQuantity": "685 units",
  "codeInfo": "GTIN: 20884521128009  LOT Numbers: 2200400154",
  "moreCodeInfo": null,
  "voluntaryMandated": "Voluntary: Firm initiated",
  "initialFirmNotification": "Letter",
  "recallInitiationDate": "2023-06-28",
  "centerClassificationDate": "2023-08-11",
  "reportDate": "2023-08-23",
  "terminationDate": null,
  "eventId": "92660",
  "productCode": null,
  "kNumbers": null,
  "rootCauseDescription": null,
  "action": null,
  "firmFeiNumber": null,
  "additionalInfoContact": null,
  "classificationLevel": 1,
  "active": true,
  "firmAddress": "15 Hampshire St, Mansfield, MA 02048-1113, United States",
  "recallAgeDays": 1087,
  "distributionNationwide": true,
  "distributionStates": ["PR"],
  "riskScore": 90,
  "openfda": null,
  "observedAt": "2026-08-14T07:37:17.542Z",
  "aiSummary": "The MAHURKAR High Pressure Triple Lumen Acute Dialysis Catheter was recalled due to an occlusion in the catheter's center lumen, caused by excessive silicone-based lubricant. This poses a serious hazard as it can lead to full catheter obstruction, delaying treatment, or cause complications such as hemolysis, embolism, or thrombosis.",
  "aiSeverity": "critical",
  "aiSeverityScore": 95,
  "error": null
}

The most complete FDA drug and device recall scraper available. It returns every field the FDA drug, device and biologics enforcement reports expose (recall number, class, product, reason, firm, distribution, code info and dates), adds the richer device recall database (product code, 510(k) numbers, root cause, firm action) and derived fields like riskScore and distributionStates, and offers optional AI summary and severity add-ons, with 15+ filters to target exactly the recalls you need.

📥 Input · 📤 Output · 💰 Pricing · ▶️ Examples

Table of contents

• What it does
• Quickstart
• Input reference
• Output reference
• Example output record
• Run via API and CLI
• Fetch results
• Billing and limits
• FAQ and troubleshooting

What it does

The actor queries the openFDA drug and device enforcement datasets, applies the filters you pass, paginates through the matching recalls, and writes one normalized record per recall to the run's dataset. Choose productType to pull drugs, devices, biologics, or all combined. Enable deviceRecallDatabase for the richer FDA device recall database, which adds product code, 510(k) numbers, root cause and firm action.

Dates are normalized to YYYY-MM-DD, missing source values are returned as null, and a set of derived fields (riskScore, distributionStates, distributionNationwide, firmAddress, recallAgeDays, classificationLevel, active) is computed on top of the raw FDA fields. Two optional AI add-ons produce a plain-English summary and a health-risk severity rating.

Quickstart

Open the actor, paste this into the input, and press Run. It returns the 10 most recent Class I device recalls, newest first.

{
  "productType": "Devices",
  "classification": "Class I",
  "sortOrder": "Newest first",
  "maxRecalls": 10
}

Leave every field empty to pull the most recent drug and device recalls combined. Add searchQuery, state, recallingFirm or a date range to narrow the results.

Input reference

Field	Type	Required	Default	Description
productType	enum	no	(all)	`` (all: drug + device), Drugs, Devices, Biologics.
deviceRecallDatabase	boolean	no	false	Pull from the richer FDA device recall database instead of enforcement reports. Adds product code, 510(k) numbers, root cause and firm action. Overrides productType (device-only).
searchQuery	string	no	(empty)	A keyword matched to the recall reason (for example contamination, sterility, malfunction), or a raw openFDA expression such as product_description:insulin or recalling_firm:Pfizer.
classification	enum	no	(any)	Hazard class: Class I (most serious), Class II, Class III. Applies to enforcement reports.
status	enum	no	(any)	Ongoing, Completed, Terminated, Pending, or Open (device recall database).
state	enum	no	(any)	Two-letter US state code of the recalling firm, for example CA, NY, NJ.
recallingFirm	string	no	(empty)	Firm or manufacturer name phrase, for example Pfizer, Medtronic, Baxter.
productDescription	string	no	(empty)	Word or phrase in the product description, for example insulin, catheter, pacemaker, vaccine.
productCode	string	no	(empty)	FDA device product code, for example LWS, DXN. Only applies to the device recall database.
city	string	no	(empty)	City of the recalling firm, for example Minneapolis, Boston.
country	string	no	(empty)	Country of the recalling firm, for example United States, Germany. Applies to enforcement reports.
voluntaryMandated	enum	no	(any)	Voluntary (firm initiated) or Mandated (FDA ordered). Applies to enforcement reports.
dateFrom	string	no	(empty)	Include recalls on or after this date (YYYY-MM-DD). Applies to dateField.
dateTo	string	no	(empty)	Include recalls on or before this date (YYYY-MM-DD). Applies to dateField.
dateField	enum	no	report_date	Which date the range applies to: report_date, recall_initiation_date, center_classification_date, termination_date.
sortOrder	enum	no	(relevance)	Newest first or Oldest first, ordered on dateField. Empty keeps openFDA relevance order.
recallNumber	string	no	(empty)	Look up one exact FDA recall number, for example D-321-2016 (drug), Z-2372-2023 (device).
eventId	string	no	(empty)	Pull every recall in one FDA recall event, for example 92660. Applies to enforcement reports.
withAiSummary	boolean	no	false	AI add-on: plain-English summary of each recall (paid).
withAiSeverity	boolean	no	false	AI add-on: health-risk severity rating with a 0-100 score (paid).
maxRecalls	integer	no	10	Maximum recall records to collect. openFDA paginates with skip up to 25000.

Filters combine with logical AND.

Output reference

One dataset item per recall. Types: string, integer, boolean, string[], object, or null when the source value is absent. The productCode through additionalInfoContact fields populate mainly from the device recall database. Fields prefixed ai populate only when the matching AI add-on is enabled.

Field	Type	Description
source	string	Which dataset the record came from (enforcement or device-recall).
endpoint	string	The openFDA endpoint queried, for example /device/enforcement.json.
recallNumber	string	FDA recall number (unique per recall).
status	string	Recall status: Ongoing, Completed, Terminated, Pending, or Open.
classification	string	Hazard class: Class I, Class II, or Class III.
productType	string	Drugs, Devices, or Biologics.
productDescription	string	Full description of the recalled product.
reasonForRecall	string	Narrative reason the product was recalled.
recallingFirm	string	Firm or manufacturer subject to the recall.
city	string	City of the recalling firm.
state	string	Two-letter state code of the recalling firm.
country	string	Country of the recalling firm.
postalCode	string	Postal code of the recalling firm.
addressLine1	string	First line of the firm street address.
addressLine2	string	Second line of the firm street address, or null.
distributionPattern	string	Free-text description of where the product was distributed.
productQuantity	string	Quantity of product in distribution.
codeInfo	string	Lot codes, GTINs, best-by dates identifying affected product.
moreCodeInfo	string	Additional code information, or null.
voluntaryMandated	string	Whether the recall was firm initiated (voluntary) or FDA mandated.
initialFirmNotification	string	How the firm first notified the public or trade.
recallInitiationDate	string	Date the firm started the recall (YYYY-MM-DD).
centerClassificationDate	string	Date the FDA center classified the recall (YYYY-MM-DD).
reportDate	string	Date the recall was first reported by the FDA (YYYY-MM-DD).
terminationDate	string	Date the recall was terminated (YYYY-MM-DD), or null if still open.
eventId	string	FDA event ID grouping related recalls.
productCode	string	FDA device product code (device recall database).
kNumbers	string[]	Related 510(k) numbers (device recall database).
rootCauseDescription	string	Root cause of the device recall (device recall database).
action	string	Firm action taken (device recall database).
firmFeiNumber	string	Firm FDA Establishment Identifier (device recall database).
additionalInfoContact	string	Additional information contact (device recall database).
classificationLevel	integer	Numeric hazard rank: 1 = Class I, 2 = Class II, 3 = Class III, null if unknown.
active	boolean	true while the recall is Ongoing, Pending or Open, otherwise false.
firmAddress	string	Single-line firm postal address, ready for CRM or mapping.
recallAgeDays	integer	Whole days between reportDate and the run time.
distributionNationwide	boolean	true when the distribution text names nationwide or all-states distribution.
distributionStates	string[]	US state codes parsed from distributionPattern.
riskScore	integer	Composite 0 to 100 hazard score combining severity, recency and distribution scope. null if severity is unknown.
openfda	object	The openFDA harmonization block when present, otherwise null.
observedAt	string	ISO 8601 timestamp of when the record was collected.
aiSummary	string	AI plain-English summary of the recall (AI).
aiSeverity	string	AI health-risk rating: low, medium, high, critical (AI).
aiSeverityScore	integer	AI severity score, 0 to 100 (AI).
error	string	null on success. On a failed run, a single item with a populated error field is written instead.

Example output record

The hero record at the top of this page is a real record from a live run (input {"productType":"Devices","classification":"Class I","withAiSummary":true,"withAiSeverity":true,"maxRecalls":10}), with the distributionPattern trimmed for length.

Run via API and CLI

Start a run and wait for it to finish, then read the dataset. Replace <TOKEN> with your Apify API token.

Run synchronously and get dataset items in one call:

curl -X POST "https://api.apify.com/v2/acts/scrapers_lat~fda-drug-device-recalls-scraper/run-sync-get-dataset-items?token=<TOKEN>" \
  -H "Content-Type: application/json" \
  -d '{"productType":"Drugs","classification":"Class I","searchQuery":"contamination","maxRecalls":25,"sortOrder":"Newest first"}'

Start a run asynchronously:

curl -X POST "https://api.apify.com/v2/acts/scrapers_lat~fda-drug-device-recalls-scraper/runs?token=<TOKEN>" \
  -H "Content-Type: application/json" \
  -d '{"deviceRecallDatabase":true,"recallingFirm":"Medtronic","maxRecalls":100}'

Apify CLI:

apify call scrapers_lat/fda-drug-device-recalls-scraper \
  --input '{"eventId":"92660"}'

Fetch results

Every run writes to a dataset. Fetch items as JSON, CSV, or Excel by changing format:

# JSON
curl "https://api.apify.com/v2/datasets/<DATASET_ID>/items?token=<TOKEN>&clean=true&format=json"

# CSV
curl "https://api.apify.com/v2/datasets/<DATASET_ID>/items?token=<TOKEN>&clean=true&format=csv"

# Paginate large datasets
curl "https://api.apify.com/v2/datasets/<DATASET_ID>/items?token=<TOKEN>&offset=1000&limit=1000"

<DATASET_ID> is returned as defaultDatasetId in the run object. Use offset and limit to page through large result sets. clean=true drops empty and internal fields.

Billing and limits

• Pay per result. You are charged per recall returned (result event). See the pricing tab for the current per-result price.
• AI add-ons are billed separately. withAiSummary and withAiSeverity are paid add-ons, charged only when they return usable output.
• No charge on failure. If a run errors, the actor writes a single item with a populated error field and does not charge for it. Empty runs cost nothing.
• Spend cap respected. Set maxTotalChargeUsd on the run; once reached, the actor stops emitting and charging further billable results.
• Free Apify plans are capped at 10 records per run. Upgrade for higher maxRecalls.
• Source pagination ceiling. openFDA allows a skip offset up to 25000 per query. For larger pulls, split the work with narrower filters or date ranges.

FAQ and troubleshooting

A run returned 0 records. Why? The filter combination matched nothing. Loosen filters (remove state or classification, widen the date range), or confirm the keyword exists in the recall reason. Zero-result runs are not charged.

How do I get product code, 510(k) numbers and root cause? Enable deviceRecallDatabase. It pulls from the richer FDA device recall database and adds productCode, kNumbers, rootCauseDescription, action and firmFeiNumber. It is device-only and overrides productType.

What is the difference between drugs, devices and biologics? Drugs and biologics come from the drug enforcement endpoint; devices from the device enforcement endpoint. productType empty combines drug and device enforcement reports.

What do the AI add-ons do? withAiSummary adds a plain-English summary. withAiSeverity adds a health-risk rating and a 0-100 score. Both are optional, paid, and charged only when they return usable output.

Why is terminationDate null? The recall is still open (Ongoing, Pending or Open), so the FDA has not set a termination date. Missing values are returned as null, never invented.

Is this an official FDA tool? No. This actor is independent and has no affiliation with the FDA or openFDA. It reads only data that is publicly available through the openFDA API. Use it in accordance with the openFDA terms of service.

Related scrapers

• openFDA Food Recalls Scraper: US FDA food recall enforcement records.
• openFDA Drug Events & Recalls Scraper: FDA drug adverse events (FAERS) and recalls.
• FDA Warning Letters Scraper: FDA warning letters with full text.
• FDA Drug Labels Scraper: structured FDA drug label data.
• NHTSA Recalls Scraper: US vehicle safety recalls and complaints.
• CPSC Recalls Scraper: US consumer product safety recalls.

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Independent tool, not affiliated with the FDA or openFDA. Accesses only publicly available openFDA data. Use in accordance with the openFDA terms of service.