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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
Jan 3, 2024 USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following ... Their is a potential that the implant curved stem may be oriented incorrectly. Class II United Orthopedic Corporation
Jan 3, 2024 USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the follow... Their is a potential that the implant curved stem may be oriented incorrectly. Class II United Orthopedic Corporation
Jan 3, 2024 USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference N... Their is a potential that the implant curved stem may be oriented incorrectly. Class II United Orthopedic Corporation
Nov 24, 2017 U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303... UOC received a customer compliant report from our distributor on October 31, 2017 which stated t... Class II United Orthopedic Corporation
Nov 24, 2017 U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Cat... UOC received a customer compliant report from our distributor on October 31, 2017 which stated t... Class II United Orthopedic Corporation
Feb 10, 2017 UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical in... The locking lever pin component of the femoral driver may become deformed and break, resulting in... Class II United Orthopedic 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.