How RecallWatch works
RecallWatch is an independent newsroom that makes U.S. medical device recalls easier to find, read, and act on. We surface the FDA’s own enforcement data in a fast, human-readable format.
Sourced from openFDA
Every record comes directly from the FDA's device enforcement report API.
Continuously updated
New enforcement reports are ingested as the FDA publishes them.
Severity-first
Recalls are graded and color-coded by FDA class so risk is obvious.
Understanding recall classes
The FDA assigns every recall a class based on the probability and severity of harm.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Use of the product may cause temporary or medically reversible adverse health consequences.
Use of the product is not likely to cause adverse health consequences.
Methodology
- We query the openFDA device/enforcement endpoint and normalize each record into a consistent schema.
- Records are de-duplicated by their FDA recall number and stored in a database for fast search and filtering.
- Plain-language headlines and summaries are derived from the recalling firm and the official recall reason.
- Dates are parsed from the FDA's reporting fields; status reflects the most recent enforcement state.
Who’s behind RecallWatch
Our coverage is bylined and reviewed by a named analyst. Read our editorial & corrections policy.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
Important disclaimer
RecallWatch is an independent project and is not affiliated with or endorsed by the U.S. Food and Drug Administration. Data is provided by openFDA “as is” and may be incomplete, delayed, or unvalidated. Do not rely on this site to make medical decisions. Always consult the official FDA record and a qualified healthcare professional.