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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

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

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DateProductReasonClassFirm
Dec 15, 2025 Plum Duo Infusion System, List Number 40002-04-01 ICU Medical received one lot of defective primary speakers from our supplier that may fail to pro... Class II ICU Medical, Inc.
Dec 15, 2025 ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021... Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... Class II ICU Medical, Inc.
Dec 15, 2025 Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: M... The console label for affected devices is missing the "DANGER" symbol. Class II LEASEIR TECHNOLOGIES SLU
Dec 15, 2025 ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 40001... Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... Class II ICU Medical, Inc.
Dec 15, 2025 ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 ... Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... Class II ICU Medical, Inc.
Dec 12, 2025 Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY,... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 4, 2025 Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model... Due to probe bags that may have a compromised or incomplete sterile pouch seal. Class II Intuitive Surgical, Inc.
Dec 3, 2025 Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1... Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Per... Class II Boston Scientific Corporation
Nov 24, 2025 LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software... Software issue only allows Concentration Limits to be defined to one digit of precision past the ... Class II ICU Medical, Inc.
Nov 24, 2025 LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Softwar... For certain customers, the Change Summary review option ceases to operate as expected for any mig... Class II ICU Medical, Inc.
Nov 13, 2025 KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus der... Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. Class II Microbiologics Inc
Oct 10, 2025 CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMa... Acute circulatory support system pump may not fit into the motor and reports received of the pump... Class II Thoratec LLC
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 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 DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 71... Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... Class II Philips Medical Systems DMC GmbH
Oct 1, 2025 CombiDiagnost R90; Model Number: 709031; Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... Class II Philips Medical Systems DMC GmbH
Oct 1, 2025 ProxiDiagnost N90; Model Number: 706110; Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... Class II Philips Medical Systems DMC GmbH
Oct 1, 2025 Precision CRF; Model Number: 706400; Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... Class II Philips Medical Systems DMC GmbH
Oct 1, 2025 DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Num... Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... Class II Philips Medical Systems DMC GmbH
Oct 1, 2025 Radiography 7300 C; Model Number: 712037; Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... Class II Philips Medical Systems DMC GmbH
Sep 11, 2025 CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (1... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (1... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12C... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 TENACIO Pump with InhibiZone; UPN: 72404429; The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 TENACIO Pump without InhibiZone; UPN: 72404420; The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
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.

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.