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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Mar 8, 2013 APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas L... Spinal Solutions is recalling the APLIF system because it is not supported by adequate testing an... Class II Spinal Solutions, LLC
Feb 20, 2013 60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a var... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Spinal Solutions, LLC
Feb 20, 2013 50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a v... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Spinal Solutions, LLC
Feb 20, 2013 50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a var... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Spinal Solutions, LLC
Feb 20, 2013 40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a var... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Spinal Solutions, LLC
Feb 20, 2013 Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm C... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Spinal Solutions, LLC
Feb 20, 2013 12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Spinal Solutions, LLC
Feb 20, 2013 14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Spinal Solutions, LLC
Feb 20, 2013 Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distrib... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Spinal Solutions, LLC
Feb 20, 2013 Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a var... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Spinal Solutions, LLC
Feb 20, 2013 45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a v... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Spinal Solutions, 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.