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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

Consumer Safety

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

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

Clear
DateProductReasonClassFirm
Jul 6, 2017 Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Us... The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm. Class II Edwards Lifesciences, LLC
Jul 5, 2017 Persona Partial Knee System, Size 8, Finishing Guide Finishing guide does not adequately account for shape differences present in Size 8 of Persona Pa... Class II Zimmer Biomet, Inc.
Jul 5, 2017 LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 M... Teleflex Medical is recalling the affected product because there may be missing or incomplete inf... Class II Teleflex Medical
Jul 5, 2017 SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold... Centurion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manu... Class II Centurion Medical Products Corporation
Jul 5, 2017 HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product... Baxter Healthcare Corporation has been made aware that users may not be following the instruction... Class II Baxter Healthcare Corporation
Jul 5, 2017 HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usa... Baxter Healthcare Corporation has been made aware that users may not be following the instruction... Class II Baxter Healthcare Corporation
Jul 5, 2017 Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold indiv... The power drill torque limiter may break during use in surgery application. Class II Orthofix Srl
Jul 5, 2017 Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/P... A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Con... Class II Roche Diagnostics Corporation
Jul 5, 2017 cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775... A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Con... Class II Roche Diagnostics Corporation
Jul 5, 2017 Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*,... After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can ... Class II Cosman Medical, LLC
Jul 5, 2017 Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Produ... A small number of batches may crack or break if exposed to certain chemicals, like certain cleani... Class II Novo Nordisk Inc
Jul 5, 2017 Phadia 1000 Instrument, Article Number 12-3800-01. The "Retry" command does not function properly which could cause a shortage of Wash and Rinse sol... Class II Phadia US Inc
Jul 4, 2017 JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is int... Three (3) complaints were identified in which the potential for utilization of the JTS Grower Dr... Class II Stanmore Implants Worldwide Ltd.
Jul 3, 2017 Beijing Syntech Laser Trixel C02 Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser Nice Station Light Based Platform surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 AVID Medical QA Pack AV10654-10 The swab stick collection device provided in a convenience kit expires prior to the kit expiratio... Class II Avid Medical, Inc.
Jul 3, 2017 Beijing Syntech Laser UL Station surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser Diode Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser UL C02 Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jun 30, 2017 DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty Product may contain the presence of melted sterile packaging upon opening. Class II Zimmer Biomet, Inc.
Jun 30, 2017 JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty For soft tissue fixation Class II Zimmer Biomet, Inc.
Jun 30, 2017 MOSAIQ Medical Charged-Particle Radiation Therapy System The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistan... Class II Elekta, Inc.
Jun 30, 2017 STOCKERT Heater-Cooler System 3T, 127V/60 Hz Plastic heat exchanger fibers separating the blood compartment from the water compartment in cert... Class II Sorin Group USA, Inc.
Jun 30, 2017 STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz Plastic heat exchanger fibers separating the blood compartment from the water compartment in cert... Class II Sorin Group USA, Inc.
Jun 30, 2017 STOCKERT Heater-Cooler System 3T, 240V/60 Hz Plastic heat exchanger fibers separating the blood compartment from the water compartment in cert... Class II Sorin Group USA, Inc.
Jun 30, 2017 STOCKERT Heater-Cooler System 3T, 208V/60 Hz Plastic heat exchanger fibers separating the blood compartment from the water compartment in cert... Class II Sorin Group USA, Inc.
Jun 30, 2017 VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used... Punctures in blister packaging that was detected during the packaging process. Class II CareFusion 303, Inc.
Jun 30, 2017 ORA System with VerifEye, Catalog Number 8065998300 For use during intraocul... Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract su... Class II Alcon Research, Ltd.
Jun 30, 2017 731 Series Ventilators running software version 05.20.00 The devices in t... A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user... Class II ZOLL Medical Corporation
Jun 30, 2017 STOCKERT Heater-Cooler System 3T, 230 V Plastic heat exchanger fibers separating the blood compartment from the water compartment in cert... Class II Sorin Group USA, Inc.
Jun 30, 2017 Heron toilet and bath chair Model 880505-01 & 880505-11 Replacement campaign on all units that have a gas spring head in aluminum. Class II R82 A/S
Jun 30, 2017 ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during int... Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract su... Class II Alcon Research, Ltd.
Jun 30, 2017 STOCKERT Heater-Cooler System 3T, 120V/60 Hz Plastic heat exchanger fibers separating the blood compartment from the water compartment in cert... Class II Sorin Group USA, Inc.
Jun 29, 2017 Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Si... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MOD... Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 17... Class II Roche Diagnostics Corporation
Jun 29, 2017 Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: S... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERIL... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STE... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STER... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx O... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on th... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 6... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on t... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator... The device can deliver an atypical amount of energy due to memory corruption inside the device. Class II Boston Scientific Corporation

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.