Browse Device Recalls
12 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 12 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 12 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Cat... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Cat... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Cat... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Num... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catal... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catal... | Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed ... | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalo... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog N... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Mode... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog N... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, LLC |
| Mar 25, 2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catal... | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Katalyst Surgical, 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.