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Browse Device Recalls

139 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 139 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 139 FDA device recalls.

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DateProductReasonClassFirm
Aug 8, 2024 Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use i... Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck ... Class II Zimmer GmbH
Aug 8, 2024 Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in to... Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck ... Class II Zimmer GmbH
May 7, 2021 Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CC... Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degre... Class II Zimmer GmbH
May 7, 2021 Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CC... Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degre... Class II Zimmer GmbH
Aug 21, 2019 Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthop... Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 4x150mm, AO, Item Number 502015403 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 2.7x125mm, AO, Item Number 502015217 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 2.5x95mm, round shaft, Item Number ST502015620 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill for 3.5mm screw, 2.5x125mm, stryker, Item Number 502015218 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill for 2.7mm screw, 2x100mm, AO, Item Number 502015208 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill for 2.7mm screw, 2x120mm, AO, Item Number ST502015212 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 V-TEK", standard-countersink, cannulated, round shaft, Item Number 28.66.110 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, AO, Item Number 502015636 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 3.2x145mm, AO, Item Number 502015650 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 CBS high, countersink, cannulated, AO, Item Number ST503004542 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 CBS high, countersink, cannulated, AO, Item Number 503004542 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill for 2.7mm screw, 2x100mm, AO, Item Number ST502015208 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number ST502015206 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015146 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 2.7x125mm, AO , Item Number ST502015217 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill for 2.7mm screw, 2x125mm, Stryker, Item Number 502015211 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 MaxiCan 4.5 countersink, cannulated, AO, Item Number 503004177 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 2.5x95mm, round shaft, Item Number 502015620 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, contra-angle, Item Number 5020... An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 4x120mm, AO, Item Number 502015402 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 V-TEK", standard-countersink, cannulated, AO, Item Number ST28.66.111 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 V-TEK", Micro-countersink, AO , Item Number ST28.66.113 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number 502015207 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number 502015206 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 26mm stop, 1.9x94mm, Stryker, Item Number 502015130 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 3x90mm, round shaft, Item Number ST502015630 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 CBS micro, countersink, cannulated, AO, Item Number ST503004541 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 4x150mm, AO, Item Number ST502015403 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 15mm stop, 1x76mm, AO , Item Number 502015115 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 2x95mm, AO, Item Number ST502015623 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 2.5x87mm, AO, Item Number 502015137 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 19mm stop, 1.9x87mm, AO, Item Number 502015131 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 V-TEK", standard-countersink, cannulated, AO, Item Number 28.66.111 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 2.5x94mm, Stryker, Item Number 502015136 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 4x90mm, round shaft, Item Number 502015640 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number ... An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill Sys2.7, 2x103mm, AO, Item Number 502015107 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 2x95mm, round shaft, Item Number ST502015619 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 V-TEK", micro-countersink, round shaft, Item Number 28.66.112 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 3.5x90mm, round shaft, Item Number 502015635 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 CBS micro, countersink, cannulated, AO, Item Number 503004541 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 3x90mm, AO, Item Number 502015631 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH

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.