Browse Device Recalls
2,115 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,115 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 2,115 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 30, 2025 | IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT1... | Dental implants were imported under temperature and storage conditions that do not comply with th... | Class II | S.I.N. Implant System Ltda |
| Jul 28, 2025 | Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model... | Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. | Class II | ORTOMA AB |
| Jul 22, 2025 | OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical ... | The potential for unsterilized product within finished product labeled as sterile. | Class II | LUMENIS, LTD. |
| Jul 21, 2025 | Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Mode... | The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. | Class II | B.Braun Medical S.A.S. |
| Jul 16, 2025 | TOPS Inserter, part of the TOPS System Instrument Set used for implantation o... | Potential for missing pins at tip of inserter. | Class II | PREMIA SPINE LTD |
| Jul 15, 2025 | Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15. | Inconsistent size terminology and color coding used on labeling | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 15, 2025 | Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. | Inconsistent size terminology and color coding used on labeling | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 14, 2025 | 3mensio Workstation (Vascular Fenestrated) software | When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (i... | Class II | PIE Medical Imaging B.V. |
| Jul 11, 2025 | BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1... | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0... | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and ... | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 11, 2025 | BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-011... | Laryngoscope handles may not illuminate as intended. | Class I | Flexicare Medical (Dongguan) Ltd. |
| Jul 10, 2025 | Multi 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-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 16, 2025 | Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis K... | Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper ... | Class II | THERAKOS DEVELOPMENT LIMITED |
| 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) |
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.