Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Oct 22, 2024 Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx ... Potential for package seal to be out of specification and the sterile barrier cannot be guarantee... Class II Carwild Corporation
Oct 22, 2024 Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of ... Potential for package seal to be out of specification and the sterile barrier cannot be guarantee... Class II Carwild Corporation
Oct 22, 2024 Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgi... Potential for package seal to be out of specification and the sterile barrier cannot be guarantee... Class II Carwild Corporation
Aug 2, 2022 FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm... Sterility with new cotton source not validated Class II Carwild Corporation

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.