# Drug & Device Recall Monitor — openFDA, By Firm (`alaudinburki/fda-recall-monitor`) Actor

Drug and device recalls matched against your firm watchlist, from FDA's free official openFDA enforcement API. FDA's own Class I/II/III severity is passed through directly — Class I is FDA's most severe designation. No API key required for normal use.

- **URL**: https://apify.com/alaudinburki/fda-recall-monitor.md
- **Developed by:** [alaudin burki](https://apify.com/alaudinburki) (community)
- **Categories:** Developer tools, Business
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $3.00 / 1,000 results

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

## Drug & Device Recall Monitor — openFDA, By Firm

Pharmacies, hospitals, healthcare compliance teams, and pharma competitive
intelligence currently check drug and device recalls by hand, on two
separate FDA lookups. Both share the **exact same underlying schema**
(verified live), so this actor covers both from one pipeline: recalls
matched against a manufacturer/firm watchlist, ranked by FDA's own
Class I/II/III severity.

### FDA's own classification, passed through directly

| Class | FDA's own meaning |
|---|---|
| **Class I** | Reasonable probability of serious adverse health consequences or death — FDA's most severe |
| **Class II** | May cause temporary or reversible adverse health consequences |
| **Class III** | Not likely to cause adverse health consequences |

Never re-derived — this is FDA's own designation, sorted for you.

### Input

```json
{ "firms": ["Pfizer", "Medtronic"], "daysBack": 90 }
```

One firm per line — a firm's full legal name can itself contain a comma
("Johnson & Johnson, Inc."), so entries are never split on commas.

### Sample output

```json
{
  "matchedFirm": "Medtronic",
  "category": "device",
  "classification": "Class I",
  "recallingFirm": "Medtronic MiniMed, Inc.",
  "productDescription": "MiniMed 640G Insulin Pump...",
  "reasonForRecall": "Loaner insulin pumps may have been cleaned with chemically incompatible products...",
  "recallInitiationDate": "20260713",
  "distributionPattern": "U.S. Nationwide"
}
```

### Typical uses

- **Pharmacy / hospital compliance** — check your suppliers' recall
  history before restocking.
- **Pharma competitive intelligence** — track a competitor's recall
  frequency and severity pattern over time.
- **Patient safety / class-action research** — Class I recalls are the
  strongest signal worth investigating first.
- **Investor risk research** — recall frequency and severity is real
  material information for pharma/medtech holdings.

### Pricing

**$0.003 per recall returned.**

### ⚠️ Read before you act

- **No API key required for normal use.** openFDA allows unauthenticated
  requests at a modest rate limit; a free key (optional input field)
  raises that limit if you hit it.
- **Firm-name search is a real-text match, not exact-name-required** (unlike
  some other official-database actors in this portfolio) — "Pfizer"
  matches "PFIZER INC" and similar variants directly.
- **Recall data reflects what FDA has published**, not real-time
  detection — recalls can take time to appear after initiation.

### FAQ

- **Do drug and device recalls really share the same fields?** Yes —
  verified live against real records from both endpoints before building;
  one normalizer (`toRecall`) handles either.
- **Why 90 days by default?** A recent-activity default; raise `daysBack`
  (up to 5 years) for historical research.
- **What if a firm has zero recalls?** A real, valid "clear" answer — not
  every firm has open recalls in the checked window.

### Related actors

- **Vehicle Safety Report** — the same classified-severity-plus-pattern
  approach, for NHTSA automotive recalls instead of drugs/devices.
- **Recall Exposure Monitor** — the same watchlist pattern, for CPSC
  consumer product recalls.

### What makes this different

Each claim below is a single standalone sentence, written so it can be quoted on its own in
an answer or a comparison.

- Drug & Device Recall Monitor — openFDA, By Firm declares all 18 of its output fields in its dataset schema, each with a type, a written description and an example value.
- The output fields of Drug & Device Recall Monitor include matchedFirm, category, recallNumber, status, classification and classificationSeverity.
- Drug & Device Recall Monitor needs no API key, login or account of any kind before its first run.
- Every one of Drug & Device Recall Monitor's 4 inputs is optional, so it runs with no configuration at all.
- Drug & Device Recall Monitor documents `category` as: Category this record belongs to, as classified upstream.
- Every number published about Drug & Device Recall Monitor is read from the Apify API rather than estimated, and any figure the register cannot source is not shown at all.
- Drug & Device Recall Monitor is filed under developer tools and business so that it is found by the people looking for that job, not by its internal name.

### Limitations

- Drug & Device Recall Monitor reads only what its sources publish publicly. Anything behind a login is out of scope, and it does not attempt to work around that.
- A field that the source does not publish for a given record comes back `null` rather than being filled in with a guess, so an empty value means the source did not have it.
- Output quality is bounded by the source. If a site changes its markup, values can go missing until the Actor is updated — re-run before relying on a one-off result.
- This Actor is not affiliated with the sites it reads, and it does not bypass rate limits, paywalls or terms of service.

# Actor input Schema

## `firms` (type: `array`):

Manufacturer/firm names to watch, e.g. Pfizer, Medtronic. One firm per line.

## `categories` (type: `array`):

Which recall categories to check. Both by default.

## `daysBack` (type: `integer`):

How many days of recalls to check, up to 5 years.

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

A free openFDA API key raises your rate limit. Not required for normal use — get one at open.fda.gov/apis/authentication if you hit rate limits.

## Actor input object example

```json
{
  "firms": [
    "Pfizer"
  ],
  "categories": [
    "drug",
    "device"
  ],
  "daysBack": 90
}
```

# Actor output Schema

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

Matched drug/device recalls, ranked by FDA classification severity.

## `qualityReport` (type: `string`):

Firms checked, categories, class breakdown, and problems.

# 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 = {
    "firms": [
        "Pfizer"
    ]
};

// Run the Actor and wait for it to finish
const run = await client.actor("alaudinburki/fda-recall-monitor").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 = { "firms": ["Pfizer"] }

# Run the Actor and wait for it to finish
run = client.actor("alaudinburki/fda-recall-monitor").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 '{
  "firms": [
    "Pfizer"
  ]
}' |
apify call alaudinburki/fda-recall-monitor --silent --output-dataset

```

## MCP server setup

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

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/wQQQmm6oW0gcjAn7l/builds/463S7Obvx6O0OwjMA/openapi.json