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.

Clear

Date	Product	Reason	Class	Firm
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
Jul 10, 2025	Micro 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-MICRO-R. Electrical wheelchair component.	Devices with firmware versions 2.3 and lower may experience timing variations between software ta...	Class I	mo-Vis BVBA
Jun 23, 2025	Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number:...	Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking...	Class I	Thoratec LLC
Jun 23, 2025	Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/...	Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking...	Class I	Thoratec LLC
Jun 17, 2025	Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Mod...	A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ...	Class II	Medtronic, Inc.
Jun 17, 2025	Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Num...	A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ...	Class II	Medtronic, Inc.
May 7, 2025	Brand Name: Valeda Light Delivery System Product Name: Light Based Device fo...	U.S. customers were shipped devices that were configured for the European Union and were unable t...	Class III	LUMITHERA INC
Mar 13, 2025	HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 10775...	Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cau...	Class I	Thoratec LLC
Feb 24, 2025	Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint...	Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and b...	Class II	Checkpoint Surgical Inc
Feb 24, 2025	Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint...	Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and b...	Class II	Checkpoint Surgical Inc
Jan 8, 2025	The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a ...	The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. T...	Class II	Ithera Medical Gmbh
Jan 3, 2025	Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000...	Their is a potential that implanted pulse generators may stop delivering therapy due to an intern...	Class II	LivaNova USA, Inc.
Jan 3, 2025	Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/...	Their is a potential that implanted pulse generators may stop delivering therapy due to an intern...	Class II	LivaNova USA, Inc.
Nov 15, 2024	Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K2401...	The warming surfaces or incubator well temperatures of the listed products may exceed the desired...	Class II	CooperSurgical, Inc.
Nov 15, 2024	Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:...	The warming surfaces or incubator well temperatures of the listed products may exceed the desired...	Class II	CooperSurgical, Inc.
Nov 15, 2024	Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Nu...	The warming surfaces or incubator well temperatures of the listed products may exceed the desired...	Class II	CooperSurgical, 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.