openFDA Medical Device Adverse Events & Recalls Scraper

Extract FDA medical device adverse events (MAUDE), device recalls and 510(k) clearances from the official openFDA API

📥 Input · 📤 Output · 💰 Pricing · ▶️ Examples

3 datasets events, recalls, 510(k)

United States coverage

JSON / CSV / Excel output formats

What you get

Each record is one MAUDE device adverse event, one device recall or one 510(k) clearance from openFDA, flattened into clean columns.

Adverse Events (MAUDE) fields:

• reportNumber: FDA report number
• mdrReportKey: internal MDR report key
• eventType: event type (malfunction, injury, death)
• dateOfEvent: date the event occurred
• dateReceived: date the FDA received the report
• deviceBrandName: device brand name
• deviceGenericName: device generic name
• manufacturerName: device manufacturer
• manufacturerStreet: manufacturer street address
• manufacturerCity, manufacturerState, manufacturerZip, manufacturerCountry: manufacturer location
• regulationNumber: the CFR regulation number the device falls under
• modelNumber, catalogNumber, lotNumber: device identifiers
• deviceClass: FDA device class
• medicalSpecialty: medical specialty area
• productCode: device product code
• implant: whether the device is an implant
• productProblems: list of reported product problems
• patientOutcomes: list of patient outcomes recorded
• reporterOccupation: occupation of the reporter
• sourceType: report source type
• eventLocation: where the event took place
• mdrText: the narrative description of the event
• observedAt: when this record was collected by the scraper

Recalls fields:

• recallNumber, status, productDescription, reasonForRecall, rootCause: recall identity and cause
• recallingFirm, city, state, postalCode: firm location
• productCode, kNumbers, firmFeiNumber: device and firm identifiers
• action, productQuantity, distributionPattern, codeInfo: recall scope
• eventDateInitiated, eventDatePosted, eventDateTerminated: recall timeline
• deviceName, deviceClass, medicalSpecialty, cfresId: device classification

510(k) Clearances fields:

• kNumber, deviceName, applicant: clearance identity
• clearanceType, decisionDescription, decisionDate, dateReceived: clearance decision
• productCode, advisoryCommittee, deviceClass, medicalSpecialty: classification
• city, state, country, postalCode, contact: applicant details
• thirdPartyReview, expeditedReview, statementOrSummary: review flags
• observedAt: when this record was collected by the scraper

Who is it for

Use case	Who benefits
Device safety surveillance and signal detection	Device safety and post-market teams
Tracking recalls for a manufacturer or device	Quality and compliance teams
Monitoring 510(k) clearances by competitors	Regulatory affairs and strategy teams
Building device incident datasets for research	Health data scientists
Feeding device intelligence into dashboards	Data engineers

Frequently Asked Questions

What datasets does this scraper cover?
It covers three openFDA device datasets for the United States: MAUDE adverse events (malfunction, injury and death reports), the device recall database, and the 510(k) premarket clearance database. Choose one with the Dataset input.

How many records can I pull in one run?
openFDA paginates with a skip offset up to 25000 records per query. For larger pulls, narrow the search keyword or the date range so each run stays under that ceiling.

How does the search work?
A simple keyword is matched to the device brand name for events, the product description for recalls, or the device name for 510(k). You can also paste a raw openFDA expression with a field, such as manufacturer_name:Medtronic or event_type:Death.

Can I filter by date?
Yes. Date From and Date To accept YYYY-MM-DD. For events this filters the FDA date received, for recalls the date initiated, and for 510(k) the decision date.

What happens to missing fields?
MAUDE reports vary in completeness, so fields openFDA does not provide for a record are returned as null. The scraper never invents values.

Example use cases

Ready-to-run example tasks, each preconfigured for a common scenario. Open one and press run, or use it as a template:

• openFDA Breast Implant Recalls Scraper: Pull FDA breast implant recall records from openFDA, with product descriptions, recall reasons, classifications, recalling firms, and initiation dates.
• openFDA Defibrillator AED Adverse Events Scraper: Collect FDA MAUDE adverse event reports for defibrillators and AEDs, including device malfunctions, patient injuries, manufacturers, and report dates.
• openFDA Hip Implant Adverse Events Scraper: Extract FDA MAUDE adverse event reports for hip implants and hip replacements, including malfunction and injury details, manufacturers, and event dates.
• openFDA Infusion Pump Recalls Scraper: Pull FDA infusion pump recall records from openFDA, with product descriptions, recall reasons, classifications, recalling firms, and initiation dates.
• openFDA Knee Implant 510(k) Clearances Scraper: Extract FDA 510(k) premarket clearance records for knee implants and knee devices, with device names, applicants, product codes, and decision dates.
• openFDA Surgical Mesh Adverse Events Scraper: Collect FDA MAUDE adverse event reports for surgical mesh implants, including malfunction and injury details, manufacturers, and event received dates.
• openFDA Ventilator Recalls Scraper: Pull FDA ventilator recall records from openFDA, including product descriptions, recall reasons, classifications, recalling firms, and initiation dates.
• Monitor Catheter Device Recalls: Monitor Catheter Device Recalls
• Track Insulin Pump Adverse Events: Track Insulin Pump Adverse Events
• Collect Pacemaker 510(k) Clearances: Collect Pacemaker 510(k) Clearances

Export, API and AI agents (x402 + MCP)

Export the scraped data to JSON, CSV or Excel, pull it as a dataset through the Apify API, or wire it into your app with no code. This web scraper and data extractor also works for bulk data extraction and scheduled runs.

For AI agents: this Actor is available on x402, Apify's agentic payment standard built with Coinbase. An AI agent can discover, pay for and run it on its own with a funded wallet and a single HTTP request: no account, no subscription, no API key and no human in the loop. It also runs as an MCP tool inside Claude, Cursor and other AI clients out of the box. Learn more about x402 agentic payments on Apify.

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This actor is an independent tool and has no affiliation with the FDA or openFDA. It only accesses data that is publicly available through the open FDA API. Use it in accordance with the openFDA terms of service.