Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Apr 30, 2024 | ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Oper... | Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Pa... | Class I | ZOLL Medical Corporation |
| Apr 30, 2024 | St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 | One lot of product has dilators that are too short and will not extend outside the introducer she... | Class II | St. Jude Medical |
| Apr 29, 2024 | Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 ... | Due to software issues, their is the potential for loss of image or a degradation of the image wh... | Class II | Verathon, Inc. |
| Apr 29, 2024 | Decompression Table Model E9011. This device applies cervical and/or lumbar d... | This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the ... | Class II | Pivotal Health Solutions, Inc. |
| Apr 29, 2024 | Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b)... | Teleflex received reports indicating an infrequent condition that, when not identified and correc... | Class I | ARROW INTERNATIONAL Inc. |
| Apr 29, 2024 | Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Sof... | Due to software issues, their is the potential for loss of image or a degradation of the image wh... | Class II | Verathon, Inc. |
| Apr 29, 2024 | Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) R... | Teleflex received reports indicating an infrequent condition that, when not identified and correc... | Class I | ARROW INTERNATIONAL Inc. |
| Apr 29, 2024 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; ... | Teleflex received reports indicating an infrequent condition that, when not identified and correc... | Class I | ARROW INTERNATIONAL Inc. |
| Apr 29, 2024 | BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Seri... | Due to software issue the device may give false "SpO2 Probe Failure" alarm | Class II | Nihon Kohden America Inc |
| Apr 26, 2024 | Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numb... | The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specif... | Class II | Exactech, Inc. |
| Apr 26, 2024 | CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11 | The H5b component may fail to amplify, resulting in an inconclusive result. | Class II | Centers For Disease Control and Prevention |
| Apr 26, 2024 | O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and ... | Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,... | Class II | Medtronic Navigation, Inc.-Littleton |
| Apr 25, 2024 | STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, l... | Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not eng... | Class II | Synthes (USA) Products LLC |
| Apr 25, 2024 | EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only | Due to saline conductivity issues, their is a potential that dilation catheters may provide inacc... | Class II | Covidien, LLC |
| Apr 24, 2024 | EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuit... | A subset of the ES4K systems do not have complete records for earth leakage testing. The earth le... | Class II | Olympus Corporation of the Americas |
| Apr 24, 2024 | smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Ste... | Packaging contained the incorrect size of femoral head from what was displayed on the label. | Class II | Smith & Nephew Inc |
| Apr 24, 2024 | Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch)... | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the ... | Class II | Lucid Diagnostics, Inc. |
| Apr 24, 2024 | MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display | We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050... | Class II | Barco N.V. |
| Apr 24, 2024 | Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch)... | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the ... | Class II | Lucid Diagnostics, Inc. |
| Apr 23, 2024 | IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System... | The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 23, 2024 | IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System... | The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785... | Class II | Siemens Healthcare Diagnostics, 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.