- Class I: Reasonable chance to cause serious health problems or death
- Class II: May cause temporary/reversible health problem
- Class III: Not likely to cause health problem or injury
- Inspecting for problems
- Repairing device
- Adjusting settings
- Re-labeling
- Destroying
- Notifying patients of problem
- Monitoring patients for health issues
WHO: Company (voluntarily) or by FDA
- Add to Medical Device Recall Database
- Public notices about recalls, market withdrawals, and safety alerts
- Weekly Enforcement Report
- Post consumer information about Class I and some Class II and III recalls
Searchable Database
- Recalls since Nov 2002
- Beginning Jan 2017, includes correction or removal actions prior to recall classification
- OpenFDA is Elasticsearch-based API that serves public FDA data
- Zipped JSON files
- Records in same format as API calls to endpoint