# FDA Medical Device Recall Scraper API - Enforcement Reports (`pink_comic/fda-device-recall-enforcement`) Actor

Search FDA-classified medical-device recall enforcement reports by recall/event ID, firm, product, class, status, geography, dates, and voluntary/mandated status. Source-linked openFDA evidence with explicit outcomes and claim limits; distinct from MAUDE and 510(k).

- **URL**: https://apify.com/pink\_comic/fda-device-recall-enforcement.md
- **Developed by:** [Ava Torres](https://apify.com/pink_comic) (community)
- **Categories:** Automation, Business
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $2.00 / 1,000 fda medical device recall enforcement scraper api evidence items

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/platform/actors/running/actors-in-store#pay-per-event

## 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 Medical Device Recall Enforcement Scraper API

Search FDA-classified medical-device recall enforcement reports from the official no-key openFDA `device/enforcement` endpoint. This focused paid actor is distinct from MAUDE adverse-event reports and 510(k) clearance records.

### Fast deterministic default

Empty input searches `status:"Ongoing" AND classification:"Class I"`, sorts by newest FDA report date, and returns one item. Maximum default charge: **$0.0021** (`$0.0001` start + `$0.002` per dataset item).

```json
{"status":"Ongoing","classification":"Class I","sort":"report_date:desc","maxResults":1}
```

### Filters

Search exact recall number or event ID; recalling firm; product-description keyword; status; Class I/II/III classification; firm state/country; initiation and report date ranges (`YYYYMMDD`); and FDA's voluntary/mandated value. Sort by report or initiation date ascending/descending. `maxResults` is a total cap of 1–1,000 and may be reduced before the source request by the Apify run charge budget.

```json
{
  "firm": "Medtronic",
  "classification": "Class I",
  "reportDateFrom": "20250101",
  "sort": "report_date:desc",
  "maxResults": 25
}
```

```json
{"recallNumber":"Z-2603-2026","maxResults":1}
```

### Output and explicit outcomes

Each found row includes retrieval time, exact source query/endpoint, FDA recall and event identifiers, classification/status, firm/location, product and code/lot details, distribution, reason, quantity, notification method, voluntary/mandated value, and relevant dates. Runs emit `FOUND`, `NO_MATCH`, `INVALID_INPUT`, `SOURCE_UNAVAILABLE`, or `CHARGE_LIMIT` rather than silently returning an empty dataset.

### Evidence boundaries

FDA enforcement reports are administrative recall evidence and openFDA states its results should be treated as unvalidated. Records can lag, change, be incomplete, or describe broad distributions and code ranges. A record does **not** prove current market status, that a particular physical product is affected, defect causation, patient harm, recall completion, safety, or the absence of other recalls. Product-name matches do not establish identity. Review current FDA recall communications, firm notices, and product identifiers before operational or clinical decisions.

Source: `https://api.fda.gov/device/enforcement.json` only. No API key is required for this bounded workflow; openFDA access limits and terms apply.

# Actor input Schema

## `recallNumber` (type: `string`):

Exact FDA recall number, such as Z-2603-2026.

## `eventId` (type: `string`):

Exact FDA recall event identifier.

## `firm` (type: `string`):

Firm name phrase searched in FDA's recalling\_firm field.

## `productKeyword` (type: `string`):

Phrase searched in FDA's product description field.

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

FDA enforcement-report status. The default is Ongoing.

## `classification` (type: `string`):

FDA recall classification. The default is Class I.

## `state` (type: `string`):

Exact state value reported for the recalling firm, commonly a two-letter US abbreviation.

## `country` (type: `string`):

Exact country value reported for the recalling firm.

## `initiationDateFrom` (type: `string`):

Inclusive recall-initiation start date in YYYYMMDD form.

## `initiationDateTo` (type: `string`):

Inclusive recall-initiation end date in YYYYMMDD form.

## `reportDateFrom` (type: `string`):

Inclusive FDA report start date in YYYYMMDD form.

## `reportDateTo` (type: `string`):

Inclusive FDA report end date in YYYYMMDD form.

## `voluntaryMandated` (type: `string`):

Exact FDA voluntary\_mandated value, for example Voluntary: Firm initiated or FDA Mandated.

## `sort` (type: `string`):

Bounded ordering by report or recall-initiation date.

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

Total paid dataset-item cap. Default one-row run costs at most $0.0021 including the start fee.

## `maxTotalChargeUsd` (type: `number`):

Optional buyer cap used to reduce maxResults before requesting FDA data. Zero uses the platform run budget.

## Actor input object example

```json
{
  "status": "Ongoing",
  "classification": "Class I",
  "sort": "report_date:desc",
  "maxResults": 1,
  "maxTotalChargeUsd": 0
}
```

# 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 = {
    "status": "Ongoing",
    "classification": "Class I",
    "sort": "report_date:desc",
    "maxResults": 1
};

// Run the Actor and wait for it to finish
const run = await client.actor("pink_comic/fda-device-recall-enforcement").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 = {
    "status": "Ongoing",
    "classification": "Class I",
    "sort": "report_date:desc",
    "maxResults": 1,
}

# Run the Actor and wait for it to finish
run = client.actor("pink_comic/fda-device-recall-enforcement").call(run_input=run_input)

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

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

```

## CLI example

```bash
echo '{
  "status": "Ongoing",
  "classification": "Class I",
  "sort": "report_date:desc",
  "maxResults": 1
}' |
apify call pink_comic/fda-device-recall-enforcement --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "command": "npx",
            "args": [
                "mcp-remote",
                "https://mcp.apify.com/?tools=pink_comic/fda-device-recall-enforcement",
                "--header",
                "Authorization: Bearer <YOUR_API_TOKEN>"
            ]
        }
    }
}

```

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/acts/hGG0BmatjKJyE5wLw/builds/qvz2YVHeJoaRYPeqJ/openapi.json