Browse Device Recalls
3 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 3 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 18, 2015 | Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series ... | Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipp... | Class II | Allergan Inc |
| Jun 18, 2015 | Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series T... | Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shippe... | Class II | Allergan Inc |
| Jun 8, 2015 | Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX4... | Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired... | Class II | Allergan Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.