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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
Jun 3, 2021 HeartWare HVAD Driveline Extension Cable, REF 100 Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Pump Accessories, REF MCS1753AK Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Outflow Graft, REF MCS1725OG Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Pump Implant Kit, REF 1153 Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Pump Implant Kit, REF 1125 Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
May 28, 2021 HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated fo... The pump has an impeller with a shroud height that did not meet the lower control limit. Class II Heartware, Inc.
May 12, 2021 Prime TC-transport chair intended for medical purposes to assist a person in... Medical devices intended for use in a healthcare facility were distributed to residential custom... Class II Stryker Medical Division of Stryker Corporation
May 7, 2021 DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrai... Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number an... Class II DePuy Orthopaedics, Inc.
Apr 6, 2021 Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Us... A longevity estimation error may occur in the early years of device life when a unipolar pacing ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021 LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Pr... The firm received a complaint regarding particulate found in the packaging foam that could contam... Class II LeMaitre Vascular, Inc.
Apr 6, 2021 Programmers - Product Usage: used to treat arrhythmias related to bradycardia... A longevity estimation error may occur in the early years of device life when a unipolar pacing ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021 Implantable Pulse Generators - Product Usage: used to treat arrhythmias relat... A longevity estimation error may occur in the early years of device life when a unipolar pacing ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021 CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias ... A longevity estimation error may occur in the early years of device life when a unipolar pacing ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Mar 26, 2021 PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electro... Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to ... Class II Radiometer Medical ApS
Mar 25, 2021 ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-D... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDB... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-... Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodge... Class II Bard Peripheral Vascular Inc
Mar 25, 2021 ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DS... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. F... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. F... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDB... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-... Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodge... Class II Bard Peripheral Vascular Inc
Mar 25, 2021 ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-... Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodge... Class II Bard Peripheral Vascular Inc
Mar 25, 2021 ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. F... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 18, 2021 VERIGENE Processor SP - Product Usage: intended for processing and identifyin... Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella sp... Class II Luminex Corporation
Mar 16, 2021 REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Pr... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF Spinning Spiros Closed Male Luer - Product Usage: provides access for th... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, A... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides acce... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: prov... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filt... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" -... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLoc... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Ve... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Sp... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Dri... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PO... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. F... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLo... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave D... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, 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.