Browse Device Recalls

2,888 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,888 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 2,888 FDA device recalls in PA.

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DateProductReasonClassFirm
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 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
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 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 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 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
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 DreamStation Auto. Non-Continuous Ventilator. Devices may possess a programming error resulting in an incorrect device configuration. Class I Philips Respironics, Inc.
Jun 30, 2025 DreamStation Auto BiPAP. Non-Continuous Ventilator. Devices may possess a programming error resulting in an incorrect device configuration. Class I Philips Respironics, Inc.
Jun 18, 2025 Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. ... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model N... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacua... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuat... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuat... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. ... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The E... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter access... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 16, 2025 HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter. Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... Class I Draeger, Inc.
Jun 16, 2025 SafeStar 60A Plus Filter. Bidirectionally breathing system filter. Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... Class I Draeger, Inc.
Jun 16, 2025 SafeStar 55 Plus Filter. Bidirectionally breathing system filter. Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... Class I Draeger, Inc.
Jun 16, 2025 SafeStar 90 Plus Filter. Bidirectionally breathing system filter. Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... Class I Draeger, 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.