Browse Device Recalls
6 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 6 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 6 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 26, 2025 | Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalo... | Due to manufactured products that deviated from established specifications and being distributed ... | Class II | DSAART LLC |
| Sep 26, 2025 | Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Cata... | Due to manufactured products that deviated from established specifications and being distributed ... | Class II | DSAART LLC |
| Sep 26, 2025 | Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numb... | Due to manufactured products that deviated from established specifications and being distributed ... | Class II | DSAART LLC |
| Sep 26, 2025 | Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Impl... | Due to manufactured products that deviated from established specifications and being distributed ... | Class II | DSAART LLC |
| Sep 26, 2025 | Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Nu... | Due to manufactured products that deviated from established specifications and being distributed ... | Class II | DSAART LLC |
| Sep 26, 2025 | Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Numb... | Due to manufactured products that deviated from established specifications and being distributed ... | Class II | DSAART LLC |
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.