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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.

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DateProductReasonClassFirm
Dec 15, 2021 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Sep 1, 2016 VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144 Adhesive border was not sticky enough. Class II CellEra 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.