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.

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DateProductReasonClassFirm
Sep 11, 2025 BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 9, 2025 Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 ... The device either indicated a failure of the piston ventilator before use or suffered a failure o... Class I Draeger, Inc.
Sep 9, 2025 Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 S... The device either indicated a failure of the piston ventilator before use or suffered a failure o... Class I Draeger, Inc.
Sep 5, 2025 Philips L12-5 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips C9-4 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips X7-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips 3D6-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips OMNI III TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips Mini Multi TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips L17-5 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips OMNI II TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips X3-1 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips S4-1 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips S5-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Aug 28, 2025 MAGNETOM Verio Dot. Model Number: 10684333. 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 One (DE). Model Number: 11689172. 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 Prisma. Model Number: 10849582. 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 Connectom.X. Model Number: 11371480. 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 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

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.