Browse Device Recalls

39,949 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,949 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 39,949 FDA device recalls.

DateProductReasonClassFirm
Jul 3, 2025 L10-4LAP Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad ... Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class II Orascoptic Surgical Acuity
Jul 3, 2025 7.5MHZ Endo Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 L8-4 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 SCNHD LA L7-4 HDI Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 BP10-5ec Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 L12-4 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 C9-3v Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 X6-1 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 C5-2 Lumify Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 mC7-2 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 C8-5 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 S9-2 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobi... an app defect that occurs when the phone is set to a right-to-left language, which causes app-pu... Class II Tandem Diabetes Care, Inc.
Jul 3, 2025 X7-2 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 L9-3 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 C8-4v Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 L12-5 38mm Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 C6-2 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a scr... Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class II Orascoptic Surgical Acuity
Jul 3, 2025 TRANSDUCER L12-5 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 2, 2025 Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1B... Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure,... Class II Stryker Corporation
Jul 2, 2025 Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-32... Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error messa... Class II Spark Biomedical Inc
Jul 2, 2025 GE HealthCare OEC 9800. GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and... Class II GE Medical Systems, LLC
Jul 2, 2025 GE HealthCare OEC 9900 Elite C-arm Systems. GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and... Class II GE Medical Systems, LLC
Jul 1, 2025 Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... Class II Carefree Surgical Specialties
Jul 1, 2025 Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... Class II Carefree Surgical Specialties
Jul 1, 2025 Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... Class II Carefree Surgical Specialties
Jul 1, 2025 Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... Class II Carefree Surgical Specialties
Jul 1, 2025 JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside ... Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potentia... Class II North American Rescue LLC.
Jun 30, 2025 Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 30, 2025 MR 7700 Model Numbers (REF): (1) 782120, (2) 782153; The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 30, 2025 SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 78... The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 30, 2025 Laser light show projectors manufactured by BLS, Model PURE 5000/10000. The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box... Class II Beyond Laser Systems, LLC
Jun 30, 2025 Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 78... The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 30, 2025 Intera 3.0T Quasar Dual Model Number (REF): 781150; The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 30, 2025 Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148; The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 30, 2025 HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The Hea... Due to a component manufacturing issue, Automated External Defibrillator may not function properl... Class II HeartSine Technologies Ltd
Jun 30, 2025 Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD... Potential for temporary loss of imaging (X-ray) functionality due to software issue. Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 30, 2025 Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143; The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 30, 2025 DreamStation Auto CPAP. Non-Continuous Ventilator. Devices may possess a programming error resulting in an incorrect device configuration. Class I Philips Respironics, Inc.
Jun 30, 2025 SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144; The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 30, 2025 Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253; The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 30, 2025 Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000. The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box... Class II Beyond Laser Systems, LLC
Jun 30, 2025 Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (... The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 30, 2025 Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SC... Cannulated fenestrated polyaxial screws may be incorrectly labeled Class II SPINEART SA
Jun 30, 2025 Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105; The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 30, 2025 Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000. The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box... Class II Beyond Laser Systems, LLC
Jun 30, 2025 Upgrade to MR 7700 Model Number (REF): 782130; The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America
Jun 30, 2025 Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) ... The potential for component failures in the Gradient Coil of the affected MR systems may act as a... Class II Philips North America

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.