Browse Device Recalls

780 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 780 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 780 FDA device recalls.

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DateProductReasonClassFirm
Mar 10, 2023 Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resu... Class I Fresenius Kabi USA, LLC
Feb 22, 2023 Automated Peritoneal Dialysis System. Used for automatic control of dialysis... The electrical safety testing was not properly performed on the impacted devices and additional t... Class II Baxter Healthcare Corporation
Feb 20, 2023 Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-ter... Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolong... Class II Moberg Research, Inc.
Jul 26, 2022 Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Co... Acidified Concentrate Distribution System potential electrical safety hazard may result in electr... Class II Isopure Corp
Jul 19, 2022 VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6... Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or... Class II Ortho-Clinical Diagnostics, Inc.
Jul 19, 2022 Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2. Screws mounting an internal power supply may come loose during shipping resulting in increased ri... Class II Myolyn Inc.
Jul 19, 2022 VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: ... Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or... Class II Ortho-Clinical Diagnostics, Inc.
Jun 28, 2022 HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1... Battery performance issues. Battery electrical faults render it unable to power the controller, u... Class I Heartware, Inc.
Jun 22, 2022 CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure mon... Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) ... Class I Integra LifeSciences Corp.
Jun 16, 2022 AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic P... Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised... Class II Fresenius Medical Care Holdings, Inc.
Jun 16, 2022 AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic P... Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised... Class II Fresenius Medical Care Holdings, Inc.
Jun 7, 2022 TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet t... Electrical component failure within the control unit. The observed failure mode is a loss of func... Class II Covidien Llc
Jun 1, 2022 Ventana HE 600 System, automated slide preparer, for use in laboratories. There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in e... Class II Ventana Medical Systems Inc
May 27, 2022 LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepanc... Class II Medtronic Neuromodulation
May 20, 2022 Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 During system tests, an increased wearing of the Image acquisition system fans has been observed.... Class II Siemens Medical Solutions USA, Inc
Apr 28, 2022 Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) Isopure received a report of a hazardous incident involving a device which had experienced an ele... Class II Isopure Corp
Apr 26, 2022 BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and c... Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect prod... Class II Beaver Visitec International, Inc.
Apr 25, 2022 CardioTek EP-TRACER Software V2.x. Device did not pass electrical safety testing for adequate insulation. Class II CardioTek BV
Apr 22, 2022 Reliance Synergy Washer/Disinfector The firm identified that when the electrical contactor component in the drying chamber of the Was... Class II Steris Corporation
Apr 11, 2022 AC-powered adjustable medical beds with built-in electric DC actuators and c... There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the poss... Class II Umano Medical, Inc.
Apr 11, 2022 AC-powered adjustable medical beds with built-in electric DC actuators and co... There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the poss... Class II Umano Medical, Inc.
Mar 15, 2022 CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... Class II Graphic Controls Acquisition Corporation
Mar 15, 2022 CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... Class II Graphic Controls Acquisition Corporation
Mar 15, 2022 CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... Class II Graphic Controls Acquisition Corporation
Mar 15, 2022 CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... Class II Graphic Controls Acquisition Corporation
Mar 15, 2022 CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... Class II Graphic Controls Acquisition Corporation
Mar 15, 2022 CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... Class II Graphic Controls Acquisition Corporation
Mar 14, 2022 ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAU... Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an I... Class II Neuralynx Inc
Feb 28, 2022 Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, ... Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... Class I Respironics California, LLC
Feb 28, 2022 Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137... Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... Class I Respironics California, LLC
Feb 28, 2022 Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (8500... Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... Class I Respironics California, LLC
Jan 25, 2022 CoolSeal Generator, REF: CSL-200-50 A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 sta... Class II Bolder Surgical, LLC
Jan 20, 2022 BenchMark ULTRA and DISCOVERY ULTRA Instruments Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of... Class II Ventana Medical Systems Inc
Dec 9, 2021 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... Class II DIXI MEDICAL USA
Dec 9, 2021 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... Class II DIXI MEDICAL USA
Dec 9, 2021 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... Class II DIXI MEDICAL USA
Dec 9, 2021 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... Class II DIXI MEDICAL USA
Dec 9, 2021 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... Class II DIXI MEDICAL USA
Dec 9, 2021 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... Class II DIXI MEDICAL USA
Dec 9, 2021 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... Class II DIXI MEDICAL USA
Dec 9, 2021 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... Class II DIXI MEDICAL USA
Dec 9, 2021 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... Class II DIXI MEDICAL USA
Nov 24, 2021 Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a ... Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... Class II Philips North America Llc
Nov 24, 2021 Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluorosco... Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... Class II Philips North America Llc
Oct 28, 2021 OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 RE... Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a ... Class II Osteomed, LLC
Oct 21, 2021 ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numb... If the system experiences an overvoltage / power surge it can cause a short circuit condition wit... Class II Philips North America Llc
Oct 21, 2021 CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numb... If the system experiences an overvoltage / power surge it can cause a short circuit condition wit... Class II Philips North America Llc
Sep 27, 2021 Cardioblate CryoFlex Surgical Ablation Console There is potential for intermittent electrical connectivity between the console and probe. Class II Medtronic Perfusion Systems
Aug 19, 2021 P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 The rear heater plate and cover assembly that contains the electrical wiring for the heaters does... Class II Fort Defiance Industries, LLC
Aug 11, 2021 SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc

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.