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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

Clear
DateProductReasonClassFirm
Oct 14, 2016 OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigati... Incorrect lot number on outer kit Class III OMNI LIFE SCIENCE
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science

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.