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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

Clear
DateProductReasonClassFirm
Mar 7, 2013 Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BG... Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold sys... Class II Orthopedic Alliance LLC
Feb 20, 2013 Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, c... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Orthopedic Alliance LLC
Feb 20, 2013 Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Orthopedic Alliance LLC
Feb 20, 2013 Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Orthopedic Alliance LLC
Feb 20, 2013 Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr can... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Orthopedic Alliance LLC
Feb 20, 2013 Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Orthopedic Alliance LLC
Feb 20, 2013 Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard ... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Orthopedic Alliance LLC
Feb 20, 2013 U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Orthopedic Alliance LLC
Feb 20, 2013 Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-302... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Orthopedic Alliance LLC
Feb 20, 2013 UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Orthopedic Alliance 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.