Browse Device Recalls
788 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 788 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 788 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 |
| 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 |
| 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 |
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.