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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

2,479 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,479 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 2,479 FDA device recalls.

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DateProductReasonClassFirm
Jan 7, 2021 Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG,... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab ... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat,... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab C... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, L... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, L... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Heal... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, ... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Dec 17, 2020 EXOGEN Ultrasound Coupling Gel Product may contain white particulates that are microbial in nature. Class II Bioventus, LLC
Dec 16, 2020 REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE ... Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... Class II Medtronic Neurosurgery
Dec 16, 2020 REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE ... Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... Class II Medtronic Neurosurgery
Dec 16, 2020 REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE ... Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... Class II Medtronic Neurosurgery
Dec 14, 2020 Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use... Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ... Class II Integra LifeSciences Corp.
Dec 14, 2020 Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: u... Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ... Class II Integra LifeSciences Corp.
Dec 11, 2020 FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: in... The software does not update measurements and calculations in the Clinical Reporting Application ... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 2, 2020 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Produ... Due to the incorrect filter assembly. Class II ICU Medical, Inc.
Dec 2, 2020 7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Produc... Due to the incorrect filter assembly. Class II ICU Medical, Inc.
Dec 2, 2020 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage:... Due to the incorrect filter assembly. Class II ICU Medical, Inc.
Dec 2, 2020 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron F... Due to the incorrect filter assembly. Class II ICU Medical, Inc.
Nov 9, 2020 icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended fo... Due to a potential software issue, the display may show the incorrect continuous cardiac output (... Class II ICU Medical, Inc.
Oct 23, 2020 Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usag... The distal tip ring of the fully articulating catheter may become dislodged during the procedure. Class II Intuitive Surgical, Inc.
Oct 19, 2020 Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral fo... Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and t... Class II Geistlich Pharma North America, Inc.
Oct 19, 2020 Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for... Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and t... Class II Geistlich Pharma North America, Inc.
Oct 19, 2020 Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for fi... Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and t... Class II Geistlich Pharma North America, Inc.
Oct 16, 2020 Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on pat... In-house lab observations and customer reports of overheating and/or thermal damage to the batter... Class II Covidien Llc
Sep 24, 2020 AMS 700 MS Pump with and without InhibiZone, sold as individual units and als... The recalling firm has observed an increase in complaints of problems encountered during the init... Class II Boston Scientific Corporation
Sep 22, 2020 ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038... When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated se... Class I Flexicare Medical Ltd.
Sep 17, 2020 Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage... A potentially shorter than specified nebulizer connector may result in difficulty in installing t... Class II Getinge Group Logistics America, LLC
Sep 11, 2020 Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Produc... The magnet located inside the foot pedal may come off and may result in unattended start of unsto... Class II Bien-Air Surgery Sa
Sep 8, 2020 MediCult Vitrification Cooling Media, Model Number 12284001F There is a discrepancy between the printing on the Product Tyvek label of the individual componen... Class II CooperSurgical, Inc.
Aug 31, 2020 Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Clos... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning S... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chambe... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx ... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, S... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip ... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260 Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 ... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30"... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chambe... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 24, 2020 Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICA... Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contain... Class II Irvine Biomedical Inc, a St. Jude Medical Co.
Aug 24, 2020 Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICA... Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contain... Class II Irvine Biomedical Inc, a St. Jude Medical Co.
Aug 18, 2020 Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "A... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-214... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 13, 2020 Critical Care Decontamination System (CCDS) Compatible N95 respirators - Pr... Masks processed at one site were not maintained at levels of condensation during a portion of the... Class II Battelle Memorial Institute

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.