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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.