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