Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 3, 2024 | ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | HA FlexTrak-Patient transport functionality to transport the patient from the... | Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resu... | Class II | Philips North America Llc |
| May 3, 2024 | ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical System... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indi... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electric... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | HA FlexTrak-Patient transport functionality to transport the patient from the... | Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resu... | Class II | Philips North America Llc |
| May 3, 2024 | FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | SmartPath to dStream for 3.0T Model Number (REF): 782145 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Sy... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 78210... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrica... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | HA FlexTrak II-Patient transport functionality to transport the patient from ... | Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resu... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 2, 2024 | GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) ... | GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a ... | Class II | GE Vingmed Ultrasound As |
| May 2, 2024 | BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; An... | If automated dispensing cabinets have specific software versions, and Component Manager was confi... | Class II | CareFusion 303, Inc. |
| May 2, 2024 | Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Softw... | Potential for pressure wave data synchronization from two devices may not be correct. | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| May 2, 2024 | GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW | GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a ... | Class II | GE Vingmed Ultrasound As |
| May 1, 2024 | Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Comp... | Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk ... | Class I | Getinge Usa Sales Inc |
| May 1, 2024 | The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-base... | Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility b... | Class II | Mermaid Medical A/S |
| Apr 30, 2024 | MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (in... | There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 30, 2024 | TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 ... | A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a fe... | Class II | Outset Medical, 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.