# FDA Device Recall Intelligence (`wakey7dev/fda-device-recall-intelligence`) Actor

Extract and normalize FDA medical device recall data with risk classification and company intelligence.

- **URL**: https://apify.com/wakey7dev/fda-device-recall-intelligence.md
- **Developed by:** [Chris Wakefield](https://apify.com/wakey7dev) (community)
- **Categories:** Business
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

Pay per usage

This Actor is paid per platform usage. The Actor is free to use, and you only pay for the Apify platform usage, which gets cheaper the higher subscription plan you have.

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

## What's an Apify Actor?

Actors are web data automations that power AI and operations. They run on the Apify platform to scrape websites, process data, connect APIs, and automate workflows.
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.
Actors are written with capital "A".

## 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.
The best way to integrate Actors is as follows.

- **AI agents and MCP clients** — the [Apify MCP server](https://docs.apify.com/integrations/mcp.md) at `https://mcp.apify.com` (remote, streamable HTTP, OAuth on first use).
- **Agentic workflows and local Actor development** — [Agent Skills](https://apify.com/.well-known/agent-skills/index.json) with the [Apify CLI](https://docs.apify.com/cli/docs.md): `npm install -g apify-cli`, then `apify login`.
- **JavaScript/TypeScript projects** — the official [JS/TS client](https://docs.apify.com/api/client/js/docs.md): `npm install apify-client`.
- **Python projects** — the official [Python client](https://docs.apify.com/api/client/python/docs.md): `pip install apify-client`.
- **Any other language** — the [REST API](https://docs.apify.com/api/v2.md).

For usage examples, see the [API](#api) section below.

For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt).

# README

## FDA Device Recall Intelligence

![Chris The Dev](https://raw.githubusercontent.com/chriswakefield87/appstore-screenshot-translator/main/assets/actor-banner.png)

Extract and normalize FDA medical device recall data with intelligent enrichment.

### Features

- **59,000+ device recalls** from OpenFDA database
- **Risk classification** (Class I/II/III) with severity analysis
- **Company name normalization** - standardizes manufacturer names
- **Product description cleaning** - removes noise, extracts key info
- **Date intelligence** - recall initiation, termination, completion dates
- **Recall status tracking** - ongoing, completed, terminated
- **Voluntary vs mandated** recall identification

### Use Cases

- **Medical device manufacturers** - competitive intelligence, recall pattern analysis
- **Healthcare providers** - risk assessment, vendor evaluation
- **Regulatory compliance** - track recall trends, identify problematic devices
- **Investors** - monitor company recall history, risk assessment
- **Legal** - product liability research, case building

### Input

```json
{
  "productDescription": "pacemaker",
  "companyName": "medtronic",
  "recallClass": "I",
  "status": "ongoing",
  "dateFrom": "2024-01-01",
  "dateTo": "2024-12-31",
  "maxResults": 100
}
```

All fields optional. Leave empty for broad search.

### Output

Returns structured recall data with:

- Recall number and status
- Product description (normalized)
- Company name (standardized)
- Risk classification (I/II/III)
- Recall dates (initiation, termination)
- Reason for recall
- Action taken
- Distribution scope

### Pricing

$2.00 per 1,000 results (PPE)

Free tier: 50 results/day
Bronze: $0.20/CU compute
Silver: $0.16/CU compute
Gold: $0.13/CU compute

### Examples

**Recent Class I recalls:**

```json
{
  "recallClass": "I",
  "maxResults": 10
}
```

**Specific company recalls:**

```json
{
  "companyName": "johnson & johnson",
  "dateFrom": "2024-01-01"
}
```

**Product category search:**

```json
{
  "productDescription": "surgical instrument",
  "maxResults": 50
}
```

### Data Source

OpenFDA device recall database (api.fda.gov) - free, no API key required.

### Notes

- Data updates continuously from FDA enforcement reports
- Company names normalized (removes Inc/LLC/Ltd, standardizes case)
- Product descriptions cleaned (removes HTML, standardizes formatting)
- Dates in ISO 8601 format (YYYY-MM-DD)
- Max 1000 results per run (API pagination limit)

# Actor input Schema

## `productDescription` (type: `string`):

Search term for product description (e.g., 'pacemaker', 'surgical instrument')

## `companyName` (type: `string`):

Manufacturer or recalling firm name

## `recallClass` (type: `string`):

FDA recall class (I=most dangerous, II=moderate, III=least dangerous)

## `status` (type: `string`):

Current status of recall

## `dateFrom` (type: `string`):

Recall initiation date start (YYYY-MM-DD)

## `dateTo` (type: `string`):

Recall initiation date end (YYYY-MM-DD)

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

Maximum number of recalls to return

## Actor input object example

```json
{
  "dateFrom": "2024-01-01",
  "dateTo": "2024-12-31",
  "maxResults": 100
}
```

# Actor output Schema

## `results` (type: `string`):

Complete dataset of normalized recall records

## `summary` (type: `string`):

Human-readable summary of recall findings

## `stats` (type: `string`):

Machine-readable statistics about the run

# 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 = {
    "dateFrom": "2024-01-01",
    "dateTo": "2024-12-31"
};

// Run the Actor and wait for it to finish
const run = await client.actor("wakey7dev/fda-device-recall-intelligence").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 = {
    "dateFrom": "2024-01-01",
    "dateTo": "2024-12-31",
}

# Run the Actor and wait for it to finish
run = client.actor("wakey7dev/fda-device-recall-intelligence").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 '{
  "dateFrom": "2024-01-01",
  "dateTo": "2024-12-31"
}' |
apify call wakey7dev/fda-device-recall-intelligence --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,wakey7dev/fda-device-recall-intelligence"
        }
    }
}
```

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/rrd7SW28u799TxgPc/builds/ES40s9jNEld3ZW0zJ/openapi.json