Browse Device Recalls

25 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 25 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 25 FDA device recalls.

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DateProductReasonClassFirm
Apr 16, 2018 AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 ... Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using compone... Class II Spinal Elements
Nov 13, 2017 Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranh... Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 ... Class II Amendia, Inc dba Spinal Elements
Apr 9, 2015 Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury ... Some rods may not meet the appropriate traceability requirements including the lot number. Some ... Class III Spinal Elements, Inc
Dec 18, 2014 Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This de... Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (a... Class II Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030.... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040.... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, 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.