FDA Recalls (Device, Drug, Food) & 510(k) Clearances Scraper — openFDA API

Extract official U.S. Food and Drug Administration (FDA) Enforcement Recall Reports (device_enforcement, drug_enforcement, food_enforcement) and 510(k) Premarket Notification Clearances (device_510k) from the official openFDA JSON APIs (api.fda.gov).

Supports deep cursor pagination via the Link: <...>; rel="next" (search_after) response header to bypass openFDA's 25,000 skip cap, normalizes all FDA YYYYMMDD dates to ISO YYYY-MM-DD, and works out of the box without an API key (or accepts an optional openFdaApiKey for 120,000 requests/day).

Who it's for

• Regulatory affairs, quality assurance (QA/RA) & compliance teams monitoring Class I, Class II, and Class III recalls across medical devices, pharmaceuticals, and food products
• MedTech commercial, competitive intelligence & BD teams tracking newly cleared 510(k) devices (kNumber, deviceName, applicant, contact, productCode, regulationNumber)
• Supply chain, hospital procurement, legal & risk management analysts auditing vendor recall histories and UDI/lot code notices (codeInfo)

Input

By default, the Actor pulls up to 200 Class I and Class II medical device enforcement recalls reported in the past 90 days.

{
  "dataset": "device_enforcement",
  "classifications": ["Class I", "Class II"],
  "statuses": ["Ongoing"],
  "keywords": ["catheter", "infusion pump"],
  "firmName": "",
  "states": ["CA", "MN"],
  "dateFrom": "2026-07-25",
  "dateTo": "2026-10-23",
  "maxItems": 200
}

Field	Type	Default	Description
dataset	string	"device_enforcement"	device_enforcement, drug_enforcement, food_enforcement, or device_510k.
classifications	array	["Class I", "Class II"]	Hazard classifications (Class I, Class II, Class III) — applies to enforcement datasets only.
statuses	array	[] (all)	Recall statuses (Ongoing, Completed, Terminated, Pending) — enforcement only.
keywords	array of strings	[] (all)	Matched in product_description or reason_for_recall (enforcement) or device_name (device_510k).
firmName	string	"" (all)	Matched against recalling_firm (enforcement) or applicant (device_510k).
states	array of strings	[] (all)	2-letter US state codes (e.g. ["CA", "MN"]).
dateFrom	string (YYYY-MM-DD)	today - 90 days	Start of report_date (enforcement; minimum 2012-06-20) or decision_date (device_510k).
dateTo	string (YYYY-MM-DD)	today	End of report_date or decision_date.
openFdaApiKey	string (secret)	""	Optional free openFDA API key (increases quota from 1,000/day to 120,000/day).
maxItems	integer	200	Maximum number of rows to output.

Output

Every output row includes a dataset field identifying the source dataset.

Enforcement datasets (device_enforcement, drug_enforcement, food_enforcement)

Field	Type	Description
dataset	string	device_enforcement, drug_enforcement, or food_enforcement
recallNumber	string | null	FDA recall number (e.g. Z-3183-2026)
eventId	string | null	FDA recall event ID
productType	string | null	Devices, Drugs, or Food
classification	string | null	Class I, Class II, or Class III
status	string | null	Ongoing, Completed, Terminated, or Pending
recallingFirm	string | null	Recalling firm name
city / state / country	string | null	Recalling firm location
reportDate	string | null	Enforcement report publication date (YYYY-MM-DD)
recallInitiationDate	string | null	Recall initiation date (YYYY-MM-DD)
centerClassificationDate	string | null	FDA classification date (YYYY-MM-DD)
terminationDate	string | null	Recall termination date (YYYY-MM-DD)
voluntaryMandated	string | null	Voluntary vs. FDA-mandated status
initialFirmNotification	string | null	Initial firm notification method
distributionPattern	string | null	Geographic distribution pattern
productDescription	string | null	Recalled product description
productQuantity	string | null	Quantity distributed
reasonForRecall	string | null	Root cause / reason for recall
codeInfo	string | null	UDI, lot, batch, or serial numbers
openfda	object | null	Cross-referenced openFDA device/drug identifiers when present

510(k) Clearances (device_510k)

Field	Type	Description
dataset	string	device_510k
kNumber	string | null	510(k) number (e.g. K262005)
deviceName	string | null	Cleared device trade name
applicant	string | null	Applicant company name
contact	string | null	Submission contact person
city / state / country	string | null	Applicant location
decisionDate	string | null	FDA decision date (YYYY-MM-DD)
decisionDescription	string | null	Decision description (e.g. Substantially Equivalent)
dateReceived	string | null	Submission receipt date (YYYY-MM-DD)
productCode	string | null	3-letter FDA product code
advisoryCommitteeDescription	string | null	Medical specialty advisory committee
regulationNumber	string | null	21 CFR regulation number
clearanceType	string | null	Traditional, Special, or Abbreviated
statementOrSummary	string | null	Summary or Statement
fdaUrl	string | null	Direct CDRH 510(k) link

Sample output row (Enforcement)

{
  "dataset": "device_enforcement",
  "recallNumber": "Z-3183-2026",
  "eventId": "99634",
  "productType": "Devices",
  "classification": "Class II",
  "status": "Ongoing",
  "recallingFirm": "Stryker Sustainability Solutions",
  "city": "Tempe",
  "state": "AZ",
  "country": "United States",
  "reportDate": "2026-09-23",
  "recallInitiationDate": "2026-08-19",
  "centerClassificationDate": "2026-09-16",
  "terminationDate": null,
  "voluntaryMandated": "Voluntary: Firm initiated",
  "initialFirmNotification": "N/A",
  "distributionPattern": "US Nationwide distribution...",
  "productDescription": "REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM",
  "productQuantity": "2838 units",
  "reasonForRecall": "Reusable access port system may crack or seperate during use.",
  "codeInfo": "UDI: (01)00885825017231/ Lots: 16188647 16210212...",
  "openfda": null
}

How pricing works

Pay per result. You only pay for rows returned.

Data source and terms

Data is pulled from the U.S. Food and Drug Administration's openFDA API (https://api.fda.gov), updated weekly from FDA Recall Enterprise System (RES) Enforcement Reports and regularly from the CDRH 510(k) database. openFDA data is provided under the openFDA license and Terms of Service.

openFDA disclaimer: 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.

Data provided by the U.S. Food and Drug Administration (https://open.fda.gov).

This Actor is an independent tool. It is not affiliated with, endorsed by or an official product of the FDA or openFDA. It reshapes openFDA records (selected fields, renamed keys, blank values returned as null) without changing their content; check the official FDA record before acting on it.

Limits and FAQ

• Why must enforcement dateFrom be >= 2012-06-20? openFDA's enforcement datasets (device/enforcement, drug/enforcement, food/enforcement) begin coverage on June 20, 2012; earlier dates are rejected up front with a clear validation message (device_510k covers clearances back to 1976).
• How are large result sets (> 25,000 rows) paginated? openFDA caps skip at 25,000, so this Actor uses limit=1000 and follows the Link: <...>; rel="next" (search_after) cursor header.

Changelog

• v0.1.2 — Added the openFDA disclaimer and a non-affiliation notice.

• v0.1.1 — Results are sorted newest first (report date for recalls, decision date for 510(k)). Blank text fields are returned as null.

• v0.1 — Initial release supporting device_enforcement, drug_enforcement, food_enforcement, and device_510k with search_after cursor pagination.