# FDA Recalls & 510(k) Clearances Scraper (openFDA API) (`groundplanes/openfda-recalls-510k`) Actor

FDA medical device, drug and food recalls (enforcement reports) and 510(k) device clearances from the public openFDA API. Filter by class, status, keyword, firm, state and date. Newest first. Regulatory monitoring and medtech competitive intelligence. No API key needed.

- **URL**: https://apify.com/groundplanes/openfda-recalls-510k.md
- **Developed by:** [John](https://apify.com/groundplanes) (community)
- **Categories:** 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 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 Recalls (Device, Drug, Food) & 510(k) Clearances Scraper — openFDA API

Extract official U.S. Food and Drug Administration (FDA) **Enforcement Recall Reports** (`device_enforcement`, `drug_enforcement`, `food_enforcement`) and **510(k) Premarket Notification Clearances** (`device_510k`) from the official openFDA JSON APIs (`api.fda.gov`).

Supports deep cursor pagination via the `Link: <...>; rel="next"` (`search_after`) response header to bypass openFDA's 25,000 `skip` cap, normalizes all FDA `YYYYMMDD` dates to ISO `YYYY-MM-DD`, and works out of the box without an API key (or accepts an optional `openFdaApiKey` for 120,000 requests/day).

### Who it's for

- **Regulatory affairs, quality assurance (QA/RA) & compliance teams** monitoring Class I, Class II, and Class III recalls across medical devices, pharmaceuticals, and food products
- **MedTech commercial, competitive intelligence & BD teams** tracking newly cleared 510(k) devices (`kNumber`, `deviceName`, `applicant`, `contact`, `productCode`, `regulationNumber`)
- **Supply chain, hospital procurement, legal & risk management analysts** auditing vendor recall histories and UDI/lot code notices (`codeInfo`)

### Input

By default, the Actor pulls up to 200 Class I and Class II medical device enforcement recalls reported in the past 90 days.

```json
{
  "dataset": "device_enforcement",
  "classifications": ["Class I", "Class II"],
  "statuses": ["Ongoing"],
  "keywords": ["catheter", "infusion pump"],
  "firmName": "",
  "states": ["CA", "MN"],
  "dateFrom": "2026-07-25",
  "dateTo": "2026-10-23",
  "maxItems": 200
}
```

| Field | Type | Default | Description |
|---|---|---|---|
| `dataset` | string | `"device_enforcement"` | `device_enforcement`, `drug_enforcement`, `food_enforcement`, or `device_510k`. |
| `classifications` | array | `["Class I", "Class II"]` | Hazard classifications (`Class I`, `Class II`, `Class III`) — applies to enforcement datasets only. |
| `statuses` | array | `[]` (all) | Recall statuses (`Ongoing`, `Completed`, `Terminated`, `Pending`) — enforcement only. |
| `keywords` | array of strings | `[]` (all) | Matched in `product_description` or `reason_for_recall` (enforcement) or `device_name` (`device_510k`). |
| `firmName` | string | `""` (all) | Matched against `recalling_firm` (enforcement) or `applicant` (`device_510k`). |
| `states` | array of strings | `[]` (all) | 2-letter US state codes (e.g. `["CA", "MN"]`). |
| `dateFrom` | string (`YYYY-MM-DD`) | `today - 90 days` | Start of `report_date` (enforcement; minimum `2012-06-20`) or `decision_date` (`device_510k`). |
| `dateTo` | string (`YYYY-MM-DD`) | `today` | End of `report_date` or `decision_date`. |
| `openFdaApiKey` | string (secret) | `""` | Optional free openFDA API key (increases quota from 1,000/day to 120,000/day). |
| `maxItems` | integer | `200` | Maximum number of rows to output. |

### Output

Every output row includes a `dataset` field identifying the source dataset.

#### Enforcement datasets (`device_enforcement`, `drug_enforcement`, `food_enforcement`)

| Field | Type | Description |
|---|---|---|
| `dataset` | string | `device_enforcement`, `drug_enforcement`, or `food_enforcement` |
| `recallNumber` | string | null | FDA recall number (e.g. `Z-3183-2026`) |
| `eventId` | string | null | FDA recall event ID |
| `productType` | string | null | `Devices`, `Drugs`, or `Food` |
| `classification` | string | null | `Class I`, `Class II`, or `Class III` |
| `status` | string | null | `Ongoing`, `Completed`, `Terminated`, or `Pending` |
| `recallingFirm` | string | null | Recalling firm name |
| `city` / `state` / `country` | string | null | Recalling firm location |
| `reportDate` | string | null | Enforcement report publication date (`YYYY-MM-DD`) |
| `recallInitiationDate` | string | null | Recall initiation date (`YYYY-MM-DD`) |
| `centerClassificationDate` | string | null | FDA classification date (`YYYY-MM-DD`) |
| `terminationDate` | string | null | Recall termination date (`YYYY-MM-DD`) |
| `voluntaryMandated` | string | null | Voluntary vs. FDA-mandated status |
| `initialFirmNotification` | string | null | Initial firm notification method |
| `distributionPattern` | string | null | Geographic distribution pattern |
| `productDescription` | string | null | Recalled product description |
| `productQuantity` | string | null | Quantity distributed |
| `reasonForRecall` | string | null | Root cause / reason for recall |
| `codeInfo` | string | null | UDI, lot, batch, or serial numbers |
| `openfda` | object | null | Cross-referenced openFDA device/drug identifiers when present |

#### 510(k) Clearances (`device_510k`)

| Field | Type | Description |
|---|---|---|
| `dataset` | string | `device_510k` |
| `kNumber` | string | null | 510(k) number (e.g. `K262005`) |
| `deviceName` | string | null | Cleared device trade name |
| `applicant` | string | null | Applicant company name |
| `contact` | string | null | Submission contact person |
| `city` / `state` / `country` | string | null | Applicant location |
| `decisionDate` | string | null | FDA decision date (`YYYY-MM-DD`) |
| `decisionDescription` | string | null | Decision description (e.g. `Substantially Equivalent`) |
| `dateReceived` | string | null | Submission receipt date (`YYYY-MM-DD`) |
| `productCode` | string | null | 3-letter FDA product code |
| `advisoryCommitteeDescription` | string | null | Medical specialty advisory committee |
| `regulationNumber` | string | null | 21 CFR regulation number |
| `clearanceType` | string | null | `Traditional`, `Special`, or `Abbreviated` |
| `statementOrSummary` | string | null | `Summary` or `Statement` |
| `fdaUrl` | string | null | Direct CDRH 510(k) link |

#### Sample output row (Enforcement)

```json
{
  "dataset": "device_enforcement",
  "recallNumber": "Z-3183-2026",
  "eventId": "99634",
  "productType": "Devices",
  "classification": "Class II",
  "status": "Ongoing",
  "recallingFirm": "Stryker Sustainability Solutions",
  "city": "Tempe",
  "state": "AZ",
  "country": "United States",
  "reportDate": "2026-09-23",
  "recallInitiationDate": "2026-08-19",
  "centerClassificationDate": "2026-09-16",
  "terminationDate": null,
  "voluntaryMandated": "Voluntary: Firm initiated",
  "initialFirmNotification": "N/A",
  "distributionPattern": "US Nationwide distribution...",
  "productDescription": "REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM",
  "productQuantity": "2838 units",
  "reasonForRecall": "Reusable access port system may crack or seperate during use.",
  "codeInfo": "UDI: (01)00885825017231/ Lots: 16188647 16210212...",
  "openfda": null
}
```

### How pricing works

Pay per result. You only pay for rows returned.

### Data source and terms

Data is pulled from the U.S. Food and Drug Administration's **openFDA API** (`https://api.fda.gov`), updated weekly from FDA Recall Enterprise System (RES) Enforcement Reports and regularly from the CDRH 510(k) database. openFDA data is provided under the [openFDA license](https://open.fda.gov/license/) and [Terms of Service](https://open.fda.gov/terms/).

**openFDA disclaimer:** *Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.*

**Data provided by the U.S. Food and Drug Administration (https://open.fda.gov).**

This Actor is an independent tool. It is not affiliated with, endorsed by or an official product of the FDA or openFDA. It reshapes openFDA records (selected fields, renamed keys, blank values returned as null) without changing their content; check the official FDA record before acting on it.

### Limits and FAQ

- **Why must enforcement `dateFrom` be `>= 2012-06-20`?** openFDA's enforcement datasets (`device/enforcement`, `drug/enforcement`, `food/enforcement`) begin coverage on June 20, 2012; earlier dates are rejected up front with a clear validation message (`device_510k` covers clearances back to 1976).
- **How are large result sets (> 25,000 rows) paginated?** openFDA caps `skip` at 25,000, so this Actor uses `limit=1000` and follows the `Link: <...>; rel="next"` (`search_after`) cursor header.

### Changelog

- **v0.1.2** — Added the openFDA disclaimer and a non-affiliation notice.

- **v0.1.1** — Results are sorted newest first (report date for recalls, decision date for 510(k)). Blank text fields are returned as null.

- **v0.1** — Initial release supporting `device_enforcement`, `drug_enforcement`, `food_enforcement`, and `device_510k` with `search_after` cursor pagination.

# Actor input Schema

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

Select which openFDA endpoint to query: device_enforcement, drug_enforcement, food_enforcement, or device_510k.

## `classifications` (type: `array`):

FDA recall hazard classifications to include (applies to enforcement datasets only). Leave empty for all classifications.

## `statuses` (type: `array`):

Optional recall statuses (Ongoing, Completed, Terminated, Pending). Leave empty for all.

## `keywords` (type: `array`):

Optional keywords matched against product_description or reason_for_recall (or device_name for device_510k).

## `firmName` (type: `string`):

Optional company name matched against recalling_firm (enforcement) or applicant (device_510k).

## `states` (type: `array`):

Optional 2-letter US state codes (e.g. \["CA", "MN", "MA"]). Leave empty for all states.

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

Start of report_date (enforcement; must be >= 2012-06-20) or decision_date (device_510k). Leave empty for today minus 90 days.

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

End of report_date (enforcement) or decision_date (device_510k). Leave empty for today.

## `openFdaApiKey` (type: `string`):

Optional free api.fda.gov key to raise the daily quota from 1,000 to 120,000 requests/day.

## `maxItems` (type: `integer`):

Maximum number of recall or 510(k) records to output.

## Actor input object example

```json
{
  "dataset": "device_enforcement",
  "classifications": [
    "Class I",
    "Class II"
  ],
  "statuses": [],
  "keywords": [],
  "firmName": "",
  "states": [],
  "maxItems": 200
}
```

# Actor output Schema

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

No description

# 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 = {
    "dataset": "device_enforcement",
    "classifications": [
        "Class I",
        "Class II"
    ],
    "statuses": [],
    "keywords": [],
    "firmName": "",
    "states": [],
    "maxItems": 200
};

// Run the Actor and wait for it to finish
const run = await client.actor("groundplanes/openfda-recalls-510k").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 = {
    "dataset": "device_enforcement",
    "classifications": [
        "Class I",
        "Class II",
    ],
    "statuses": [],
    "keywords": [],
    "firmName": "",
    "states": [],
    "maxItems": 200,
}

# Run the Actor and wait for it to finish
run = client.actor("groundplanes/openfda-recalls-510k").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 '{
  "dataset": "device_enforcement",
  "classifications": [
    "Class I",
    "Class II"
  ],
  "statuses": [],
  "keywords": [],
  "firmName": "",
  "states": [],
  "maxItems": 200
}' |
apify call groundplanes/openfda-recalls-510k --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,groundplanes/openfda-recalls-510k"
        }
    }
}
```

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/NW5G071b97SkaSh14/builds/TXq1f4OV8SDObjBBv/openapi.json