Browse Device Recalls

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 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 3,664 FDA device recalls, Class I.

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DateProductReasonClassFirm
Feb 13, 2025 smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF... The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... Class I Smiths Medical ASD, Inc.
Feb 5, 2025 Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x... Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce th... Class I Bard Peripheral Vascular Inc
Feb 5, 2025 Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code... There is the potential for missing motor mounting screws, which may have occurred during the serv... Class I Baxter Healthcare Corporation
Feb 5, 2025 Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUA... Unexpected loose material in the male luer used in the aortic root cannula has been identified. P... Class I Medtronic Perfusion Systems
Feb 5, 2025 Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX There is the potential for missing motor mounting screws, which may have occurred during the serv... Class I Baxter Healthcare Corporation
Feb 3, 2025 VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: ... Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause ... Class I Ventec Life Systems, Inc.
Jan 30, 2025 Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: P... Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wal... Class I Micro Therapeutics, Inc.
Jan 30, 2025 Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: P... Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wal... Class I Micro Therapeutics, Inc.
Jan 15, 2025 Olympus Single Use Guide Sheath Kits with the following product descriptions ... Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into ... Class I Olympus Corporation of the Americas
Jan 15, 2025 Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a componen... Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk ... Class I Getinge Usa Sales Inc
Jan 13, 2025 Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY). Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 72228... Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281... Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY). Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026, Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221. Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD10C; Catalog number: 722001 Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY). Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY). Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD20/10; Catalog numbers: 722029 Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035. Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD20/15; Catalog numbers: 722058 Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD20/20; Catalog numbers: 722038 Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025. Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027. Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236. Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013. Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028. Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 13, 2025 Allura CV20; Catalog numbers: 722031 Possibility of the patient falling from the table related to the mattress used on the patient table. Class I PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 10, 2025 Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use ... Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: ... Class I Fresenius Kabi USA, LLC
Jan 10, 2025 Intact Vascular Tack Endovascular System, to treat vascular dissections with ... Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of a... Class I Spectranetics Corporation
Jan 5, 2025 VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Cathe... Due to an observed trend of neurovascular events Class I Biosense Webster, Inc.
Dec 31, 2024 Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600... The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess materia... Class I MEDLINE INDUSTRIES, LP - Northfield
Dec 31, 2024 Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item N... The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess materia... Class I MEDLINE INDUSTRIES, LP - Northfield
Dec 26, 2024 regard Item Number: 830106006, LD01114F - Newborn Kit containing the componen... There is a potential for the Inline Controller to be using the spring out of specification causin... Class I ROi CPS LLC
Dec 23, 2024 VDR4 Phasitron Breathing Circuit Models that contain the venturi component: ... Due to internal venturi component getting transiently stuck in the forward position within the br... Class I Percussionaire Corporation
Dec 20, 2024 Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A There is an issue with the ventilator battery charger that could lead to an audible and visual al... Class I Baxter Healthcare Corporation
Dec 20, 2024 Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP There is an issue with the ventilator battery charger that could lead to an audible and visual al... Class I Baxter Healthcare Corporation
Dec 20, 2024 Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in... Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power a... Class I Max Mobility LLC
Dec 20, 2024 Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use i... Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power a... Class I Max Mobility LLC
Dec 20, 2024 Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP There is an issue with the ventilator battery charger that could lead to an audible and visual al... Class I Baxter Healthcare Corporation
Dec 20, 2024 Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002 There is an issue with the ventilator battery charger that could lead to an audible and visual al... Class I Baxter Healthcare Corporation
Dec 18, 2024 Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number... Potential for inadvertent retention of biomaterial when the reprocessing procedure is not perform... Class I Olympus Corporation of the Americas
Dec 18, 2024 Monitoring Service Application (MSA). Software to process, analyze, display, ... Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and ... Class I Braemar Manufacturing, LLC
Dec 16, 2024 Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-... Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the req... Class I MEDLINE INDUSTRIES, LP - Northfield
Dec 16, 2024 Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2... Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the req... Class I MEDLINE INDUSTRIES, LP - Northfield
Dec 12, 2024 Impella RP with SmartAssist; Product Number: 0046-0035; Optical Sensors have been damaged due to physical interaction between the inlet and another devic... Class I Abiomed, Inc.
Dec 12, 2024 VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228) A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... Class I Boston Scientific Corporation
Dec 12, 2024 ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... Class I Boston Scientific Corporation

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.