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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.

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DateProductReasonClassFirm
Feb 2, 2022 NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and ma... NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather ... Class II Ace Surgical Supply Co., Inc.
Mar 28, 2018 Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to ach... The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead ... Class II Ace Surgical Supply Co., Inc.
Feb 22, 2017 INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Strai... Incorrect device was packaged. Class II Ace Surgical Supply Co., 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.