Openfda Device Recall Extractor

Status: ✅ Working - Uses official OpenFDA public API

Best for

This actor queries the OpenFDA Device Recall API to fetch medical device recall records including safety alerts, enforcement actions, and recall classifications.

API Endpoint

• Base URL: https://api.fda.gov
• Recalls Endpoint: /device/enforcement.json
• Documentation: https://open.fda.gov/apis/device/enforcement/

Capabilities

• Search by device name, product type, or keywords
• Filter by recall class (A, B, C)
• Returns normalized recall records with all FDA enforcement data

Input

Field	Type	Required	Default	Description
queries	string[]	Yes	-	List of device names, manufacturers, or keywords
maxItemsPerQuery	number	No	100	Maximum number of recall records per query
recallClass	string	No	""	Filter by recall class: "A", "B", or "C"
includeRaw	boolean	No	false	Attach raw API response to each record

Example input

{
  "queries": ["defibrillator", "pacemaker"],
  "maxItemsPerQuery": 100,
  "recallClass": "A",
  "includeRaw": false
}

Output

Field	Type	Description
source	string	Always "openfda-device-recall"
query	string	The original search query
recordType	string	Always "medical_device_recall"
title	string	Company name + recall number
identifier	string	FDA recall number
date	string	Recall event date
url	string	FDA enforcement page URL
summary	string	Human-readable summary
recallingFirm	string	Company that issued recall
recallClass	string	Recall class (A, B, or C)
recallStatus	string	Current status (Terminated, Ongoing, etc.)
productTypes	array[]	List of recalled products
recallReasons	array[]	List of reasons for recall
raw	object	(Optional) Raw API response

Example output

{
  "source": "openfda-device-recall",
  "query": "defibrillator",
  "recordType": "medical_device_recall",
  "title": "Boston Scientific - 2019-2168-1",
  "identifier": "2019-2168-1",
  "date": "2019-11-15",
  "url": "https://www.fda.gov/safety/recalls",
  "summary": "Boston Scientific (2019-2168-1) - Class A (most serious), Ongoing. Products: Implantable defibrillators. Reason: Battery depletion",
  "recallingFirm": "Boston Scientific Corporation",
  "recallClass": "A",
  "recallStatus": "Ongoing",
  "productTypes": ["Cardiac Rhythm Management Devices"],
  "recallReasons": ["Battery may deplete earlier than expected"]
}

Recall Classifications

• Class A: Reasonable probability that use will cause serious adverse health consequences or death
• Class B: Remote probability of serious adverse health consequences but possible
• Class C: Unlikely to cause adverse health consequences

Notes

• Rate Limits: OpenFDA allows ~15 requests/minute per IP
• Data Freshness: FDA data is updated regularly but may have slight delays
• Search Limitations: Query syntax must follow OpenFDA rules
• No Pagination: Use query terms to refine results; max 1000 per request

Additional notes

Run npm run check to verify syntax:

$npm run check

Additional notes

• OpenFDA Device Enforcement API: https://api.fda.gov/device/enforcement.json
• FDA Recalls: https://www.fda.gov/safety/recalls

Pricing

This actor uses the Apify Pay-Per-Event model at $0.002 per dataset item.

Example cost: 1,000 items ≈ $2 in actor charges (plus standard Apify platform compute).