Browse Device Recalls
2,968 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,968 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 2,968 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Jun 4, 2025 | UROSKOP Omnia. Model Number: 10094910 | A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housi... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2025 | UROSKOP Omnia Max. Model Number: 10762473 | A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housi... | Class II | Siemens Medical Solutions USA, Inc |
| May 28, 2025 | Philips S7-3t Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips L9-3 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips L8-4 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips VL13-5 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips L12-4 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips C5-1 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips XL14-3 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips S8-3t Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips X5-1 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips X7-2t Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips 3D9-3v Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips S7-2 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips S5-1 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips V6-2 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips X8-2t Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips X6-1 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips L12-3 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips C5-2 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | 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.