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Vehicle Safety

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

4,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,602 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 4,602 FDA device recalls in CA.

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DateProductReasonClassFirm
Apr 9, 2021 COVID-19 Self-Test Kit *** INNOVA *** 7T Due to distributing test kits to customers who were not part of a clinical investigation. Class I INNOVA MEDICAL GROUP, INC.
Apr 9, 2021 For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-... Due to distributing test kits to customers who were not part of a clinical investigation. Class I INNOVA MEDICAL GROUP, INC.
Apr 9, 2021 COVID-19 Self-Test Kit *** INNOVA *** 3T Due to distributing test kits to customers who were not part of a clinical investigation. Class I INNOVA MEDICAL GROUP, INC.
Mar 26, 2021 Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair wit... Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump mo... Class I Infusion Pump Repair
Mar 24, 2021 Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by ... Aftermarket front bezel components were installed during service/repair, not by the original manu... Class I Pacific Medical Group Inc.
Mar 23, 2021 Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 23, 2021 Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 23, 2021 Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal 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.
Mar 16, 2021 REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port L... 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 CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/Che... 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 CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClav... 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 CH2060 60mL 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 CL3946 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 15, 2021 ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assur... Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufact... Class I St. Jude Medical, Cardian Rhythm Management Div...
Mar 15, 2021 MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PU... Due to a software design issue, under certain conditions, a software fault is detected when a lar... Class II Medtronic Minimed
Mar 15, 2021 ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rh... Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufact... Class I St. Jude Medical, Cardian Rhythm Management Div...
Mar 15, 2021 MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ ... Due to a software design issue, under certain conditions, a software fault is detected when a lar... Class II Medtronic Minimed
Mar 3, 2021 BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module... Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module contin... Class I CareFusion 303, Inc.
Feb 26, 2021 Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neopla... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable,... Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthm... Class II CAIRE DIAGNOSTICS INC
Feb 26, 2021 Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - ... There is a potential for tube trays to leak which could potentially result in false positive res... Class II Hologic, Inc
Feb 26, 2021 Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, M... Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or u... Class II Stryker 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.