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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 28, 2025 | MAGNETOM Verio Dot Upgrade. Model Number: 10684334. | There is a potential for an ice blockage to form or currently exist within the magnet venting sys... | Class I | Siemens Medical Solutions USA, Inc |
| Aug 28, 2025 | MAGNETOM Cima.X (DE). Model Number: 11647158. | There is a potential for an ice blockage to form or currently exist within the magnet venting sys... | Class I | Siemens Medical Solutions USA, Inc |
| Aug 28, 2025 | MAGNETOM Skyra fit. Model Number: 10849580. | There is a potential for an ice blockage to form or currently exist within the magnet venting sys... | Class I | Siemens Medical Solutions USA, Inc |
| Aug 28, 2025 | MAGNETOM Vida Fit. Model Number: 11410481. | There is a potential for an ice blockage to form or currently exist within the magnet venting sys... | Class I | Siemens Medical Solutions USA, Inc |
| Aug 28, 2025 | MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K... | There is a potential for an ice blockage to form or currently exist within the magnet venting sys... | Class I | Siemens Medical Solutions USA, Inc |
| Aug 28, 2025 | MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. | There is a potential for an ice blockage to form or currently exist within the magnet venting sys... | Class I | Siemens Medical Solutions USA, Inc |
| Aug 28, 2025 | MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837... | There is a potential for an ice blockage to form or currently exist within the magnet venting sys... | Class I | Siemens Medical Solutions USA, Inc |
| Aug 28, 2025 | MAGNETOM Lumina (DE). Model Number: 11344916. | There is a potential for an ice blockage to form or currently exist within the magnet venting sys... | Class I | Siemens Medical Solutions USA, Inc |
| Aug 28, 2025 | MAGNETOM Verio. Model Number: 10276755. | There is a potential for an ice blockage to form or currently exist within the magnet venting sys... | Class I | Siemens Medical Solutions USA, Inc |
| Aug 28, 2025 | Biograph mMR. Model Number: 10433372. | There is a potential for an ice blockage to form or currently exist within the magnet venting sys... | Class I | Siemens Medical Solutions USA, Inc |
| Aug 28, 2025 | MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111... | There is a potential for an ice blockage to form or currently exist within the magnet venting sys... | Class I | Siemens Medical Solutions USA, Inc |
| Aug 12, 2025 | Artis Pheno. Image-Intensified Flouroscopic X-Ray System. | Limited system movements after startup . | Class II | Siemens Medical Solutions USA, Inc |
| Aug 6, 2025 | ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. ... | Potential for undetected, deformed a-traumatic tips. | Class I | Olympus Corporation of the Americas |
| Jul 25, 2025 | Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Gen... | Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Er... | Class II | Olympus Corporation of the Americas |
| Jul 25, 2025 | Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Gen... | Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Er... | Class II | Olympus Corporation of the Americas |
| Jul 9, 2025 | Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for us... | Label is incorrect. The product label indicates that the device contains an air eliminating filte... | Class I | B BRAUN MEDICAL INC |
| Jul 3, 2025 | X3-1 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 | S7-2t 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 | S12-4 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 | S8-3 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 | C9-5ec 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 | 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 | 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 | 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 |
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.