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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

806 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 806 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 806 FDA device recalls.

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DateProductReasonClassFirm
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Dec 14, 2012 Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm... Some of the individual extension set packages were improperly sealed, compromising the sterility ... Class II Baxter Healthcare Corp.
Nov 20, 2012 The Centricity Laboratory System is intended to be an information system desi... GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Labor... Class III GE Healthcare It
Nov 16, 2012 Centricity Enterprise Archive is a software product for receiving, archiving ... There is a potential for data loss associated with empty path names resulting from HL-7 updates w... Class II Ge Healthcare It
Nov 14, 2012 Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Tr... RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining i... Class II Leica Microsystems, Inc.
Nov 9, 2012 Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A ... Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or be... Class II SpineFrontier, Inc.
Nov 5, 2012 Laparoscope, general; plastic surgery Used for general, abdominal, gynecol... Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shi... Class II Applied Medical Resources Corp
Nov 5, 2012 OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC Th... Failure of glue joint, allowed a portion of the single use device to shift inside, may separate a... Class II OmniGuide, Inc.
Sep 25, 2012 ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation S... The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation ... Class II Alphatec Spine, Inc.
Sep 13, 2012 Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary... A complaint received from sales representative that a replenishment instrument was too short. Upo... Class II OrthoPediatrics Corp
Sep 7, 2012 Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Sep 7, 2012 Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clear... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Sep 7, 2012 Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Bur... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Sep 7, 2012 Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clear... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Aug 31, 2012 Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro M... Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at ti... Class II Accuro Medical Product LLC
Aug 21, 2012 Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0... The firm is recalling the product due to some cartridges may contain individual discs that are no... Class II Remel Inc
Jul 17, 2012 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of product... BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... Class II Nico Corp.
Jul 17, 2012 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of product... BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... Class II Nico Corp.
Jul 5, 2012 Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spi... Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable... Class II Stryker Spine
Jun 6, 2012 AirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Do... Internal data identified a molding defect in the 15 mm O.D. / I.D. MiniSpacer meter dose inhaler ... Class II Thayer Medical Corporation
Jun 5, 2012 PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrume... Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove ... Class II Zimmer, Inc.
Jun 5, 2012 Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle hand... Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been ... Class II Zimmer, Inc.
Jun 5, 2012 Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight h... Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been ... Class II Zimmer, Inc.
May 29, 2012 Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 a... GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mis... Class II GE Healthcare, LLC
May 21, 2012 Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxi... Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure... Class II Natus Medical Incorporated
May 11, 2012 The product is Pathfinder SL, version 1.6.0.3057 software used with the Space... The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter ... Class II Spacelabs Healthcare, Llc
May 9, 2012 The product has the Catalogue/Part number 60010. Olympic Cool-Cap System i... The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occur... Class I Natus Medical Incorporated
May 7, 2012 CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose dr... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc
May 7, 2012 CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromag... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc
May 7, 2012 CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromag... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc
May 7, 2012 CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromag... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc
May 7, 2012 CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose dr... The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... Class II Civco Medical Instruments Inc
Apr 23, 2012 GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Produ... GE Healthcare has recently become aware of a potential issue due to image flip in frequency encod... Class II GE Healthcare, LLC
Apr 9, 2012 "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 1... ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect ... Class II Linvatec Corp. dba ConMed Linvatec
Apr 6, 2012 TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Mo... Invacare Corporation decided to recall the product because of a potential risk of fire and seriou... Class II Invacare Corporation
Mar 27, 2012 MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal phot... The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator ma... Class II Nidek Inc
Mar 22, 2012 Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529 The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Mar 22, 2012 PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Mar 22, 2012 PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit,... The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Mar 22, 2012 PrepStain Syringing Pipettes 240 (Catalog #490517) The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Mar 22, 2012 PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523 The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... Class III Tripath Imaging, Inc.
Mar 15, 2012 Sunquest Laboratory Sunquest Laboratory is intended for use by professiona... Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, ... Class II Sunquest Information Systems, Inc.
Jan 26, 2012 Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Pr... Stryker has become aware that there exists a potential for breach of the sterile barrier of packa... Class II Stryker Howmedica Osteonics Corp.

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.