Browse Device Recalls

38,683 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 38,683 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 38,683 FDA device recalls.

DateProductReasonClassFirm
Jul 3, 2025 Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw... Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class II Orascoptic Surgical Acuity
Jul 3, 2025 C10-3v 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 L17-5 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 Orascoptic Superior Visualization Custom loupes configured with Phantom Frames Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class II Orascoptic Surgical Acuity
Jul 3, 2025 X7-2t 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 L15-7IO TRANSDUCER 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 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 D2TCD 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 Custom loupes with Dragonfly frames Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class II Orascoptic Surgical Acuity
Jul 3, 2025 OMNI III TEE 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 L11-3 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 C9-3io 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 X8-2t 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 XL14-3 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 V9-2 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 L12-5 50 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 C9-4 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 V6-2 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 c5-1 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 L12-3 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 S5-2 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 L12-4 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 X5-1c 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 L15-7io 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 eL18-4 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 D2cwc 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 3D9-3v 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 C9-2 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 S4-1 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 X5-1 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 S4-1 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 Mini Multi TEE 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 X11-4t 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 Transducer C10-3v 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 D5cwc 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 S8-3t 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 S3-1 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 C9-4v 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 3D6-2 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 S7-3t 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 mC12-3 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 C6-3 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 mL26-8 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 Nose Pad Accessory Kit ( nose pa... Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class II Orascoptic Surgical Acuity
Jul 3, 2025 L18-5 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 OMNI II TEE 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 S4-2 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 VL13-5 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 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 C10-4ec Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, 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.