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 |
|---|---|---|---|---|
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | Design Options, Pain Management Tray. Product Code: SESK. Product Description... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Prod... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 ... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 11, 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 | 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 MP60 | 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 | 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 1TQ180 | 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-1TH190 | 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 P60 | 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-P190 | 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 b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 | 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-Q190 | 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 1T150 | 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-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 |
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.