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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

4,686 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,686 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 4,686 FDA device recalls in CA.

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DateProductReasonClassFirm
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Ca... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) M... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Mod... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
Oct 9, 2025 Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/... Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/appro... Class II Myofunctional Research Company USA
Oct 6, 2025 Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are batt... Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or ma... Class I Tandem Diabetes Care, Inc.
Oct 2, 2025 IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w... IV Gravity burette administration set burette component is missing an internal shutoff valve inte... Class I ICU Medical, Inc.
Oct 1, 2025 Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control,... The firm received complaints from customers reporting vial-to-vial variability when using the con... Class II Microgenics Corporation
Sep 30, 2025 Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 11... Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Sep 30, 2025 All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00 Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Sep 30, 2025 Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-0... Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Sep 30, 2025 Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139... Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Sep 30, 2025 BD Pyxis Pro MedStation Main, REF: 1155-00 Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... Class II CareFusion 303, Inc.
Sep 30, 2025 Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with... Incorrect titanium screw, packaged with dental implant. Class II Prismatik Dentalcraft, Inc.
Sep 25, 2025 Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression... Class II DJO, LLC
Sep 25, 2025 Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast ... Due to an identified manufacturing defect involving coating material lifting within the catheter'... Class I BALT USA, LLC
Sep 23, 2025 iLet Bionic Pancreas, REF: BB1001 The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all... Class II Beta Bionics, Inc.
Sep 22, 2025 DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 T... Due to a software error code that crashes during acquisition on patient sample when running custo... Class II Beckman Coulter Inc.
Sep 18, 2025 Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Cat... Software issue for hq analyzer results in system not visibly applying appropriate flagging to res... Class II Abbott Laboratories
Sep 17, 2025 SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL... Class II Beckman Coulter Inc.
Sep 12, 2025 Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number:... Due to Users not having access to the Instructions for Use/User Manual due to it being password p... Class II Noah Medical Corporation
Sep 11, 2025 BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, ... Infusion pump module used with compatible pump infusion sets may perform outside the establishe... Class I CareFusion 303, Inc.
Sep 8, 2025 MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 150995907205... Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. Class II Beckman Coulter, Inc.
Sep 8, 2025 ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, C... Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ChemoLock Bag Spike, 01 units REF: CL-10-10 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Grad... Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoL... Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, C... Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Conne... Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLoc... Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connect... Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical ChemoLock Closed Vial Spike REF: CL-80 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical ChemoLock Bag Spike REF: CL-10 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, ... Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock"... Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical ChemoLock Port REF: CL2100 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLoc... Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Sep 8, 2025 ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/... Port weld of drug transfer device may separate or break during use and potentially result in a l... 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.