Browse Device Recalls

797 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 797 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 797 FDA device recalls.

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DateProductReasonClassFirm
Jul 20, 2026 Dentsply Sirona Capsule Mixer Model No. 5546068 Potential for electrical discharge from unit when unplugged. Class II SDI Limited
Jul 7, 2026 Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powere... Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss ... Class II Olympus Corporation of the Americas
Jun 30, 2026 GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the ... The module did not undergo electrical safety tests and functional tests during production. Class II Maquet Critical Care AB
May 13, 2026 Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Sti... A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... Class II Medtronic Neuromodulation
May 13, 2026 Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Sti... A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... Class II Medtronic Neuromodulation
May 11, 2026 Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory ... Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf ... Class II Inspire Medical Systems Inc.
May 6, 2026 Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of th... It has been identified that the impacted docking station (SN 2521008873) was not product released... Class II Stryker Corporation
Apr 30, 2026 Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI ... Due to incorrect shelf-life expiration date. Class II Advanced Bionics, LLC
Apr 24, 2026 CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer b... Class II GE Medical Systems Information Technologies Inc
Apr 20, 2026 Allia IGS 7 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
Apr 20, 2026 Allia IGS 5 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
Apr 20, 2026 Allia Moveo angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
Apr 20, 2026 Allia IGS Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
Apr 20, 2026 Allia IGS 3 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
Mar 26, 2026 Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command M... Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). Class II Spacelabs Healthcare, Inc.
Mar 12, 2026 Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula ... Class I Insulet Corporation
Feb 25, 2026 Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS C... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Dec 15, 2025 Allura Xper FD20; Model Number: 722006; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD10; Model Number: 722026; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD20 Biplane; Model Number: 722013; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD20 OR Table; Model Number: 722023; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD20 Biplane; Model Number: 722008; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD10; Model Number: 722010; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD20/10; Model Number: 722029; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD20; Model Number: 722012; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD10/10; Model Number: 722005; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD20/20; Model Number: 722038; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD10/10; Model Number: 722011; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD10; Model Number: 722003; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Product Name: Allura Xper FD10C; Model number: 722001; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD20; Model Number: 722028; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD10/10; Model Number: 722027; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD10F; Model Number: 722002; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 14, 2025 Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, ... Due to a manufacturing issue and electrical grounding of systems. Class II Elekta, Inc.
Dec 12, 2025 Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman ... Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Mi... Class II Integra LifeSciences Corp. (NeuroSciences)
Dec 10, 2025 MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a ... Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical b... Class II REPLIGEN CORPORATION
Nov 19, 2025 AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product De... Wire connected to the electrical box may shift out of its intended position, which may result in ... Class II Steris Corporation
Nov 19, 2025 AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Des... Wire connected to the electrical box may shift out of its intended position, which may result in ... Class II Steris Corporation
Oct 16, 2025 VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Affected system contains components that do not meet the required distance between electrodes for... Class II Canon Medical System, USA, INC.
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
Sep 18, 2025 HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-P... Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanic... Class II HeartSine Technologies Ltd
Aug 12, 2025 Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in... Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... Class I Max Mobility LLC
Aug 12, 2025 Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in ... Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... Class I Max Mobility LLC
Aug 12, 2025 Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use i... Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... Class I Max Mobility LLC
Jul 10, 2025 Multi Joystick R-net. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA
Jul 10, 2025 IDM-MULTI-R. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA
Jul 10, 2025 All-round Joystick R-net Light. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA
Jul 10, 2025 IDM-ARLITE-R. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA

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.