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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.