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
May 20, 2026 Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor... Due to an incomplete process of the component screw by a subcontractor which prevents the properl... Class II United Orthopedic Corp.
May 20, 2026 Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and ... Due to an incomplete process of the component screw by a subcontractor which prevents the properl... Class II United Orthopedic Corp.
May 20, 2026 Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PS... Due to an incomplete process of the component screw by a subcontractor which prevents the properl... Class II United Orthopedic Corp.
May 20, 2026 Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left ... Due to an incomplete process of the component screw by a subcontractor which prevents the properl... Class II United Orthopedic Corp.
Mar 19, 2026 Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm a... Due to a design issue causing the incorrect engraved numbering on implant that could result in th... Class II United Orthopedic Corp.
Mar 19, 2026 Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm a... Due to a design issue causing the incorrect engraved numbering on implant that could result in th... Class II United Orthopedic Corp.

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.