# FDA Drug, Device & Food Recall Enforcement & Legal Lead API (`mehdad-datalabs/fda-product-recalls-safety-enforcement-b2b-scraper`) Actor

Extract official US FDA Class I, II & III drug, medical device, and food recall enforcement actions (openFDA) into clean JSON/CSV. Get Recalling Firm Names, HQ Addresses, Recall Reasons, Severity Classes & Product Quantities. Built for mass-tort law firms, quant funds, n8n & MCP AI.

- **URL**: https://apify.com/mehdad-datalabs/fda-product-recalls-safety-enforcement-b2b-scraper.md
- **Developed by:** [Mehdad Sharifi](https://apify.com/mehdad-datalabs) (community)
- **Security:** Limited permissions
- **Stats:** 1 total users, 0 monthly users, 0.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $5.00 / 1,000 extracted fda recall records

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.

Learn more: https://docs.apify.com/actors/running/actors-in-store.md#pay-per-event

## What's an Apify Actor?

An Actor is a serverless cloud program that runs on the Apify platform. It has two run modes.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.

Apify vocabulary and the platform model are defined once, in the agent quickstart at https://apify.com/agents.md.

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.

Do not guess an integration path. Every one of them is in the agent quickstart at https://apify.com/agents.md: the Apify MCP server, Agent Skills with the Apify CLI, the JavaScript and Python clients, the REST API, and the account-free path for an agent with no human to sign in. It also carries the rule on stating cost before the first paid run.

For examples already wired to this Actor's own input schema, see the [API](#api) section below.

Each client library has reference documentation the quickstart does not restate: [JavaScript/TypeScript](https://docs.apify.com/api/client/js/docs.md) (`npm install apify-client`) and [Python](https://docs.apify.com/api/client/python/docs.md) (`pip install apify-client`).

# README

## FDA Drug, Medical Device & Food Recall Enforcement & Legal Lead Scraper API

Extract official US Food and Drug Administration (openFDA Enforcement) Class I, Class II, and Class III product recalls and safety enforcement actions across Pharmaceuticals (DRUG), Medical Devices (DEVICE), and Food and Beverages (FOOD) directly into clean JSON, CSV, or Excel datasets.

Built for mass-tort and product liability law firms, short-selling hedge funds, supply-chain QA and regulatory compliance teams, n8n and Make automation workflows, and AI agents (Claude MCP and Cursor)—with zero proxy fees required.

***

### Why Choose This FDA Drug, Device & Food Recall Scraper?

| Feature | What You Get |
| :--- | :--- |
| Multi-Domain FDA Recall Coverage | Switch seamlessly between FDA Drug Enforcement (DRUG), Medical Device Enforcement (DEVICE), and Food Enforcement (FOOD) recall databases in one unified API. |
| Class I, II & III Severity Filtering | Isolate critical Class I life-threatening recalls from moderate Class II or minor Class III labeling recalls with a single filter. |
| Recalling Manufacturer B2B Details | Captures the exact Recalling Firm Name, physical street address, city, state, postal code, country, voluntary vs. FDA-mandated status, and nationwide distribution pattern. |
| Exact Recall Reason & Product Quantity | Extracts the detailed root-cause defect or contamination reason (reasonForRecall), full product description, and total number of affected units or lots. |
| Zero Proxy or API Key Costs | Connects directly to official US Government api.fda.gov endpoints—blazing fast and zero residential proxy costs. |

***

### What Data Does This Actor Extract? (Sample JSON Output)

Every FDA recall enforcement action is structured into a clean, flat JSON record:

```
{
  "recallNumber": "Z-1842-2026",
  "productDomain": "DEVICE",
  "recallingFirm": "CARDIAC RHYTHM MEDICAL SYSTEMS INC.",
  "classification": "Class I",
  "severitySignal": "CLASS I (Critical / Life-Threatening Risk - High Litigation & Stock Catalyst)",
  "status": "Ongoing",
  "reportDate": "2026-10-14",
  "recallInitiationDate": "2026-09-22",
  "reasonForRecall": "Potential premature battery depletion in implantable pacemaker pulse generators may result in sudden loss of pacing therapy.",
  "productDescription": "Model 4200 Implantable Dual-Chamber Pacemaker Pulse Generator",
  "productQuantity": "14,250 units",
  "voluntaryOrMandated": "Voluntary: Firm initiated",
  "distributionPattern": "Nationwide in the US and internationally to EU and Canada",
  "address1": "4500 MEDTECH PARKWAY",
  "city": "MINNEAPOLIS",
  "state": "MN",
  "postalCode": "55413",
  "country": "US",
  "matchedQuery": "Pacemaker"
}
```

***

### How to Use FDA Recall Enforcement & Legal Lead Scraper

1. Select FDA Recall Domain: Choose DRUG (Pharmaceuticals & Biologics), DEVICE (Medical Devices & Diagnostics), or FOOD (Food, Beverages & Dietary Supplements).
2. Enter Search Keywords or Company Names: Add one or more defect keywords, device types, or manufacturer names (e.g., Pacemaker, Infusion, Sterile, Contamination, Abbott, Baxter).
3. Filter by Severity Class: Choose ALL, or isolate CLASS_I_HIGHEST_RISK for the most severe product recalls.
4. Set Max Recall Records: Choose how many recall enforcement records to extract per run (default: 30, up to 500+).
5. Run & Export: Click Start and download your dataset in JSON, CSV, Excel, or XML, or connect directly via the Apify REST API.

***

### FDA Recall Severity Classifications Reference

| FDA Class | Official Risk Definition | Commercial & Trading Signal |
| :--- | :--- | :--- |
| Class I | Reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. | Highest Signal — Primary lead source for mass-tort plaintiff law firms and a major bearish stock catalyst for public manufacturers. |
| Class II | Use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. | Moderate Signal — Ideal for B2B regulatory remediation consultants, GMP auditing firms, and contract manufacturing (CMO) outreach. |
| Class III | Use of, or exposure to, a violative product is not likely to cause adverse health consequences (typically minor packaging or labeling defects). | Low Signal — Used for supply-chain quality benchmarking and packaging vendor outreach. |

***

### Transparent Pay-Per-Event Pricing

You only pay for the exact FDA recall records extracted:

- Actor Startup (apify-actor-start): USD 0.01 per run.
- Extracted FDA Recall (fda-recall-extracted): USD 0.005 per parsed FDA recall enforcement record (USD 5.00 per 1,000 recalls).
- Free Tier Friendly: With Apify's free USD 5.00 monthly credit, you can extract nearly 1,000 FDA recall enforcement records every month for free.

***

### Top Use Cases

- Mass-Tort & Product Liability Law Firms: Automatically monitor new Class I medical device and pharmaceutical recalls (such as implantable devices, surgical mesh, infusion pumps, or contaminated drugs) to identify high-value mass-tort litigation campaigns early.
- Short-Selling & Healthcare Equity Research: Track material FDA enforcement actions against public MedTech, pharma, and consumer packaged goods (CPG) companies before quarterly earnings calls.
- B2B QA, Sterilization & Regulatory Consulting Leads: Reach out to recalling manufacturers with GMP remediation consulting, third-party lab testing, or contract sterilization services right when they need compliance help.
- Hospital & Pharmacy Supply-Chain Monitoring: Automate daily recall checks in n8n or Make to alert hospital procurement teams when medical devices or drugs in their inventory are recalled.

***

### Frequently Asked Questions (FAQ)

#### Where does this FDA recall data come from?

All records are extracted directly from the official U.S. Food and Drug Administration (openFDA) Weekly Enforcement Reports across the Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Center for Food Safety and Applied Nutrition (CFSAN).

#### What is the difference between a Class I and Class II FDA recall?

A Class I recall is the most urgent and severe FDA enforcement action, issued only when a defective drug, medical device, or food product poses a reasonable probability of serious injury or death. A Class II recall involves products that may cause temporary or medically reversible health issues.

#### How can I connect this FDA Recall API to Python, Google Sheets, Clay, or n8n?

You can trigger this Actor via the Apify REST API, the apify-client Python or Node.js SDK, or the native Apify integration node inside n8n, Make, Clay, and Zapier to automatically route recall alerts to Slack, Telegram, Google Sheets, or your CRM.

***

### Explore Our Complete 20-API Financial, Biotech & B2B Intelligence Suite

- [SEC Form 4 Insider Trading Scraper & XML Parser API](https://apify.com/mehdad-datalabs/sec-form-4-insider-trading-scraper-xml-parser-api)
- [SEC Form 13F Institutional Holdings & Hedge Fund Whale Scraper](https://apify.com/mehdad-datalabs/sec-13f-institutional-holdings-hedge-fund-whale-scraper)
- [SEC Form N-PORT Mutual Fund & ETF Portfolio Holdings API](https://apify.com/mehdad-datalabs/sec-nport-etf-mutual-fund-holdings-xml-scraper)
- [SEC 10-K & 10-Q XBRL Financial Statements & Earnings API](https://apify.com/mehdad-datalabs/sec-10k-10q-xbrl-financial-statements-earnings-api)
- [SEC Form 8-K Corporate Events, M\&A & Executive Change Scraper](https://apify.com/mehdad-datalabs/sec-8k-corporate-events-ma-executive-change-scraper)
- [SEC Schedule 13D & 13G Activist Investor & 5%+ Ownership API](https://apify.com/mehdad-datalabs/sec-schedule-13d-13g-activist-investor-ownership-api)
- [SEC Form S-1 IPO Pipeline & Form 144 Insider Sale Notice API](https://apify.com/mehdad-datalabs/sec-ipo-s1-form144-insider-sale-scraper)
- [SEC Form D Startup Funding, VC Raise & Founder B2B Lead API](https://apify.com/mehdad-datalabs/sec-form-d-startup-funding-vc-b2b-lead-scraper)
- [SEC DEF 14A Executive Compensation & Proxy Statement API](https://apify.com/mehdad-datalabs/sec-def14a-ceo-executive-compensation-proxy-scraper)
- [SEC Form 20-F & 6-K Global ADR & Foreign Stock Filings API](https://apify.com/mehdad-datalabs/sec-20f-6k-foreign-adr-international-stock-scraper)
- [CFPB Fintech & Bank Consumer Complaint Intelligence API](https://apify.com/mehdad-datalabs/cfpb-fintech-bank-consumer-complaint-b2b-scraper)
- [FDIC US Bank Directory, Deposits, Assets & B2B Lead API](https://apify.com/mehdad-datalabs/fdic-us-bank-directory-deposits-assets-b2b-scraper)
- [FDA 510(k) Medical Device Clearances & MedTech B2B Lead API](https://apify.com/mehdad-datalabs/fda-510k-medical-device-clearances-medtech-b2b-scraper)
- [US Pharmacy, Clinical Lab & Medical Supply B2B Lead API](https://apify.com/mehdad-datalabs/us-pharmacy-medical-lab-dme-b2b-lead-scraper)
- [US Public Company B2B Directory, SIC & HQ Phone API](https://apify.com/mehdad-datalabs/us-public-company-b2b-profile-sic-hq-phone-scraper)
- [US Federal Government Contract Awards & DoD B2B Lead Scraper](https://apify.com/mehdad-datalabs/us-federal-government-contract-awards-dod-b2b-scraper)
- [FDA Drug Approvals, NDA/BLA Biotech Catalyst & Pharma API](https://apify.com/mehdad-datalabs/fda-drug-approvals-biotech-catalyst-pharma-b2b-scraper)
- [ClinicalTrials.gov Phase 1-3 Biotech Catalyst & B2B Lead API](https://apify.com/mehdad-datalabs/clinical-trials-biotech-catalyst-cro-b2b-lead-scraper)
- [US Doctor, Dentist & Medical Clinic B2B Lead Scraper API](https://apify.com/mehdad-datalabs/us-doctor-dentist-clinic-healthcare-b2b-lead-scraper)

# Actor input Schema

## `productCategory` (type: `string`):

Select which FDA enforcement database to extract recalls from: 'DRUG' (Pharmaceuticals), 'DEVICE' (Medical Devices), or 'FOOD' (Food & Beverages).

## `searchKeywords` (type: `array`):

Enter company names, product keywords, or defect reasons to filter FDA recalls.

## `classificationFilter` (type: `string`):

Class I = Most serious (reasonable probability of serious adverse health consequences or death).

## `maxResults` (type: `integer`):

Maximum number of FDA recall enforcement records to extract.

## Actor input object example

```json
{
  "productCategory": "DEVICE",
  "searchKeywords": [
    "Pacemaker",
    "Infusion",
    "Sterile"
  ],
  "classificationFilter": "ALL",
  "maxResults": 30
}
```

# Actor output Schema

## `dataset` (type: `string`):

Clean table of official US FDA product recalls, recalling companies, severity classifications, reasons for recall, and distribution patterns

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {};

// Run the Actor and wait for it to finish
const run = await client.actor("mehdad-datalabs/fda-product-recalls-safety-enforcement-b2b-scraper").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = {}

# Run the Actor and wait for it to finish
run = client.actor("mehdad-datalabs/fda-product-recalls-safety-enforcement-b2b-scraper").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print(f"💾 Check your data here: https://console.apify.com/storage/datasets/{run.default_dataset_id}")
for item in client.dataset(run.default_dataset_id).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{}' |
apify call mehdad-datalabs/fda-product-recalls-safety-enforcement-b2b-scraper --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,mehdad-datalabs/fda-product-recalls-safety-enforcement-b2b-scraper"
        }
    }
}
```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/WP6lUXyPQTFDyJbbV/builds/dzcYf2VLgV0zj6bWD/openapi.json