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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
Apr 8, 2019 Drill, contra-angle, 1.5x85mm, Item Number 502015706 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 2.5x95mm, AO, Item Number ST502015621 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 ST502015635 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 502015623 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 ST502015650 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351 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 ST502015640 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 2.5x135mm, AO, Item Number 502015142 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 2.8x120mm, AO, Item Number 502015628 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 CBS high, countersink, cannulated, round-shaft, Item Number 503004342 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 502015619 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 28.66.113 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145 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, 2.5x120mm, AO, Item Number 502015216 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 ST502015207 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 CBS 7.5 tap, cannulated, AO, Item Number 503002041 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120 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 502015212 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 ST502015402 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628 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, 15mm stop, AO, Item Number 503004352 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 502015630 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 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 2.8x150mm, AO, Item Number 502015629 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, 2.5x120mm, AO, Item Number ST502015216 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 2.5x95mm, AO, Item Number 502015621 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 CBS micro, countersink, cannulated, round-shaft, Item Number 503004341 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 ST502015631 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, contra-angle, 1.5x85mm, Item Number ST502015706 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 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 50... An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Oct 31, 2018 Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.0... Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller ... Class II Zimmer GmbH
Mar 15, 2018 Normed Charcot Osteotome Chisel (Various sizes) Product may contain a gap between the handle and metal chisel which can lead to failure to proper... Class II Zimmer GmbH
Feb 28, 2018 Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01)... A potential commingle that could result in the product in the package not matching the product o... Class II Zimmer GmbH
Feb 28, 2018 Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)... A potential commingle that could result in the product in the package not matching the product o... Class II Zimmer GmbH
May 11, 2017 Normed General Instruments 503004541: Werber Countersink Cannulated for micr... the devices used a different raw material to produce two countersink products which has higher h... Class II Zimmer Gmbh
Jun 30, 2016 Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint meta... Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging o... Class II Zimmer Gmbh
Jun 27, 2016 TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes... Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a pot... Class II Zimmer Gmbh
Jun 27, 2016 TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill hole... Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a pot... Class II Zimmer Gmbh
Jun 27, 2016 V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill ho... Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a pot... Class II Zimmer Gmbh
Jun 27, 2016 V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill ho... Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a pot... Class II Zimmer Gmbh
May 17, 2016 Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder ... In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from... Class II Zimmer Gmbh
Sep 3, 2015 Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Na... In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged oute... Class II Zimmer Gmbh
Mar 18, 2015 Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total ... Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once att... Class II Zimmer Gmbh
Dec 17, 2014 Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in ... Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... Class II Zimmer Gmbh
Dec 17, 2014 CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in ske... Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... Class II Zimmer Gmbh
Dec 17, 2014 Metasul Femoral Head - A modular head component is used in conjunction with a... Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... Class II Zimmer Gmbh
Dec 17, 2014 Metasul Femoral Head - indicated for total hip arthroplasty for treatment of... Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... Class II Zimmer Gmbh
Dec 17, 2014 CoCr Femoral Head - A modular head component is used in conjunction with a fe... Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... Class II Zimmer Gmbh
Sep 4, 2012 Anatomical Shoulder" Ball taper for humeral stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, 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.