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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.

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DateProductReasonClassFirm
May 17, 2016 Calix T PEEK Lumbar System, TLIF Rasp The trials and rasps used to prepare the surgical site for placement of the implant may become de... Class II X Spine Systems Inc
May 17, 2016 Calix P PEEK Lumbar System, PLIF Rasp The trials and rasps used to prepare the surgical site for placement of the implant may become de... Class II X Spine Systems Inc
May 17, 2016 Calix P PEEK Lumbar System, PLIF Trial The trials and rasps used to prepare the surgical site for placement of the implant may become de... Class II X Spine Systems Inc
May 17, 2016 Calix T PEEK Lumbar System, TLIF Trial The trials and rasps used to prepare the surgical site for placement of the implant may become de... Class II X Spine Systems Inc
Apr 7, 2015 Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine System... The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. Class II X Spine Systems Inc
Mar 11, 2015 Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation devi... One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x... Class II X Spine Systems Inc
Jul 11, 2014 Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the S... Revision B of the tissue shields of the device was 7 mm longer than the previous design. Class II X Spine Systems Inc

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.