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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

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DateProductReasonClassFirm
Apr 11, 2017 Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 Part of the number on the tray lid differ from the part number on the base. Class II Biomet Microfixation, LLC
Jun 13, 2016 Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure o... Potential sterility deficiency. Class II Biomet Microfixation, LLC
Aug 6, 2015 Thinflap System Case The cases hold surgical instrumentation in place during... The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user withou... Class II Biomet Microfixation, LLC
Aug 6, 2015 Neuro Combo Set Case The cases hold surgical instrumentation in place during... The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user withou... Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand R... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand R... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Re... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand ... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Rec... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Rec... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Oct 17, 2014 Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand R... Laser etching on the parts is wider and deeper than the conditions previously validated. Class II Biomet Microfixation, LLC
Sep 20, 2013 Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa... Product mix occurred prior to final package and labeling process. Class II Biomet Microfixation, 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.