Medical Device Recalls
This database contains Medical Device Recalls classified since November 1, 2002. Beginning January 3, 2017, the database includes correction or removal actions initiated by a firm prior to recall classification. The status of the action is updated if the FDA identifies a violation and classifies the action as a recall and again when the recall is terminated. Recalls for medical devices regulated by the Center for Biologics Evaluation and Research may not be included in this database. CBER recall information is available here. Learn More...
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- 510(k)s
- De Novo
- Medical Device Reports (MAUDE)
- CDRH Export Certificate Validation (CECV)
- CDRH FOIA Electronic Reading Room
- CFR Title 21
- CLIA
- Device Classification
- FDA Guidance Documents
- Humanitarian Device Exemption
- Medsun Reports
- Premarket Approvals (PMAs)
- Post-Approval Studies
- Postmarket Surveillance Studies
- Radiation-Emitting Products
- Radiation-Emitting Electronic Products Corrective Actions
- Registration & Listing
- Standards
- Total Product Life Cycle
- X-Ray Assembler