# Drug & Device Safety Atlas

> A source-backed catalog of U.S. FDA drug and device recalls (enforcement actions), built from openFDA. 12,421 recall records (2,738 drug, 9,683 device) since 2023-01-01.

Read this first; it governs everything below:
- A recall is a **RECORDED FDA enforcement action** — the FDA logged that a firm is removing or correcting a product. The **classification** (Class I/II/III) is the FDA's **risk judgment**, not a measurement of harm.
- A recall does **NOT** establish that any specific unit is affected or caused harm; **causation is not established**.
- This surface **informs and compares**. It is **NOT medical advice** and never tells anyone to start or stop a drug or device. Route medical decisions to a licensed pharmacist/prescriber and the FDA recall record.
- Most recalls are Class II/III. No fearbait.

## Recall classes (the FDA's risk judgment)

- **Class I** — reasonable probability of serious harm or death. 1,603 records.
- **Class II** — temporary or medically reversible harm. 10,396 records.
- **Class III** — unlikely to cause harm. 422 records.

## Modules

- **Recalls** (per-recall) — every FDA drug/device recall enforcement record. Browse + search: https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls · page `/recalls/<recall_number>` (e.g. https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/d-0115-2026)
- **Recalls by manufacturer** (per-firm) — a manufacturer's whole FDA recall history: count, Class I/II/III severity mix, drug-vs-device, recurring reasons, ongoing count. Browse (firms with 2+ recalls, ranked): https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/firm · page `/recalls/firm/<slug>` (+ `.md`/`.jsonld`). A recall count is NOT a quality verdict — Class I + ongoing are the signal; keyed by exact firm name (no fuzzy merge).
- **Recalls by drug** (per-generic) — "is MY medication recalled?", by the generic drug name a patient knows. Each generic's recalls with Class I + ongoing first, the brands, reasons, and per-recall lot codes. Browse/search: https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/drugs · page `/recalls/drugs/<slug>` (+ `.md`/`.jsonld`). SCOPE: drug recalls the FDA recorded with a generic name (devices + unnamed recalls are in the full /recalls browse). CRITICAL: a recall is by LOT — a generic match does NOT mean a given patient's pills are affected (check the recall's lot codes); the Class is the FDA's risk judgment, not measured harm; not medical advice.
- [Methodology & sources](https://drug-device-safety-atlas.ryanjhunter.workers.dev/methodology) — openFDA enforcement, grain, and the honesty framing.

## Machine-readable formats

Every recall page also serves `.jsonld` (agent-native JSON-LD: RECORDED facts vs the FDA's risk JUDGMENT, with one explicit interpretation boundary) and `.json` (the raw recall record).
- Recall: `/recalls/<recall_number>.jsonld` · `.json`

## Data

- Source: openFDA drug & device enforcement (recall) reports, https://open.fda.gov/apis/drug/enforcement/
- Report a problem: FDA MedWatch, https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
- [Sitemap](https://drug-device-safety-atlas.ryanjhunter.workers.dev/sitemap.xml)