Browse Device Recalls

2,049 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,049 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 2,049 FDA device recalls in N/A.

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DateProductReasonClassFirm
Jul 10, 2025 IDM-MULTI-R. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA
Jul 10, 2025 All-round Joystick R-net Light. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA
Jul 10, 2025 IDM-ARLITE-R. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA
Jul 10, 2025 Micro Joystick R-net. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA
Jul 10, 2025 IDM-MICRO-R. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA
Jun 30, 2025 Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SC... Cannulated fenestrated polyaxial screws may be incorrectly labeled Class II SPINEART SA
Jun 30, 2025 Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SC... Cannulated fenestrated polyaxial screws may be incorrectly labeled Class II SPINEART SA
Jun 27, 2025 Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working leng... Affected product show elevated cytotoxicity values. Use of affected injection needles may present... Class II Spiggle & Theis Mt Gmbh
Jun 20, 2025 Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine ... Unintended radial detector motion may occur during patient setup or during patient scan if system... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Jun 20, 2025 Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine s... Unintended radial detector motion may occur during patient setup or during patient scan if system... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Jun 19, 2025 Portable X-ray system Some DIOX-602 units currently in use within the United States do not meet the minimum SSD require... Class II DIGIMED CO., LTD
Jun 18, 2025 Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard e... Natus received two complaints of left side labeling show impedance for right side. Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Jun 12, 2025 Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA i... Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary inj... Class II Immunotech A.S.
Jun 5, 2025 Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog... Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly ... Class II Waismed Ltd.
Jun 5, 2025 Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog ... Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly ... Class II Waismed Ltd.
Jun 4, 2025 Azurion 7 M20. Fluoroscopic X-Ray System. Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 3, 2025 Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021Z... A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This... Class I Hamilton Medical AG
Jun 3, 2025 Bravo CF capsule delivery device, designed to place and attach a pH monitorin... It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead ... Class I Given Imaging Ltd.
May 6, 2025 PhenoMATRIX AI-powered bacterial culture plate interpretation and workup software does not have Premarket App... Class II Copan WASP
Apr 30, 2025 Sample probe sucks a sample dispensed into a tube or cup and discharges the ... Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to... Class II Beckman Coulter Mishima K.K.
Apr 30, 2025 Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the... HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach. Class II Maquet Cardiopulmonary Ag
Apr 30, 2025 Sample probe sucks a sample dispensed into a tube or cup and discharges the ... A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S p... Class II Beckman Coulter Mishima K.K.
Apr 25, 2025 AcoSound. Model Number: LW12-BTE-M Three issues 1. Label error: The manufacturer information in the labeling is not correct, the m... Class III HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
Apr 23, 2025 Apo B Reagent, REF: OSR6143 The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value... Class III Beckman Coulter Ireland, Inc.
Apr 22, 2025 Brand Name: Catalyst+ Product Name: C4D software used in conjunction with ... Software issue with scanning equipment that can results in the filed rotation not being applied c... Class II C-RAD POSITIONING AB
Apr 16, 2025 Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, wi... software issue that causes an error screen on a portable vital signs monitor when attaching video... Class II Remote Diagnostic Technologies Ltd.
Apr 15, 2025 Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00... Patient Monitor software update to address issues:1)May freeze at startup with MPM Application er... Class II Remote Diagnostic Technologies Ltd.
Apr 10, 2025 Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical ... A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previo... Class II Tornier S.A.S.
Apr 7, 2025 Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB ... Vials of implant bone granules may contain less product then specified on labeling. Class II SCIENCE & BIO MATERIALS
Apr 7, 2025 IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number... An issue was identified with the software when using the Echo Module of ISCV, the issue may resul... Class II Philips Medical Systems Nederland B.V.
Apr 4, 2025 Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: M... Potential for internal fastening mechanism within generator of mobile x-Ray to fail. Class II Micro-X Ltd.
Apr 4, 2025 Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MX... Potential for internal fastening mechanism within generator of mobile x-Ray to fail. Class II Micro-X Ltd.
Apr 3, 2025 L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm),... The device was delivered with a preassembled Femoral Augment screw that was missing its thread. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Apr 3, 2025 Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (... The device was delivered with a preassembled Femoral Augment screw that was missing its thread. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Apr 3, 2025 Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 8... The device was delivered with a preassembled Femoral Augment screw that was missing its thread. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Apr 3, 2025 Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulato... Potential for exoskeleton to lose lateral balance and cause patient to fall. Class II WANDERCRAFT SAS
Apr 3, 2025 Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm)... The device was delivered with a preassembled Femoral Augment screw that was missing its thread. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Apr 2, 2025 HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software ... There is a leakage issue associated with the tubing in the manifold of the instrument. Class II Leica Biosystems Melbourne Pty Ltd
Apr 2, 2025 Washer Disinfector Aquadis 56; Model Number: 56A The frequency inverter is not programmed by supplier according to specification which causes the ... Class II Getinge Disinfection Ab
Apr 2, 2025 Washer Disinfector Aquadis 56; Model Number: 56M The frequency inverter is not programmed by supplier according to specification which causes the ... Class II Getinge Disinfection Ab
Apr 1, 2025 myQA iON; Article Number: MQ10-000; Wrong analysis results can occur if the user creates two structures with the same name, except fo... Class II IBA Dosimetry GmbH
Mar 27, 2025 Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate... Class II IHB OPERATIONS B.V.
Mar 26, 2025 The Trimble RTS873 robotic total station is a solution designed for construct... An issue has been identified in the production of the RTS873 robotic total stations that may resu... Class II Trimble Ab
Mar 21, 2025 GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radio... ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 a... Class II Radiometer Medical ApS
Mar 21, 2025 GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.

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.