Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
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 Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet ... Class II Siemens Healthcare Diagnostics, Inc.
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 15, 2025 ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet ... Class II Siemens Healthcare Diagnostics, Inc.
Apr 14, 2025 Plus Initial Drill, Article Number: 103.170; The referred batch was produced without the laser engraving of 7 mm. Class II Straumann USA LLC
Apr 14, 2025 Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of th... The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the t... Class II Augmedics Ltd.
Apr 14, 2025 Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI cod... Due to packaging mix up. Package of finished devices were reported to have an incorrect finished... Class II Prismatik Dentalcraft, Inc.
Apr 14, 2025 VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, o... Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and ca... Class II Ortho-Clinical Diagnostics, Inc.
Apr 13, 2025 Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit R... Due to non-sterile products being labeled as sterile Class II Microtek Medical, Inc.
Apr 11, 2025 Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09. During internal product testing, it was observed that some packages to have incomplete seals (ste... Class II LeMaitre Vascular, Inc.
Apr 11, 2025 TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651... During internal product testing, it was observed that some packages to have incomplete seals (ste... Class II LeMaitre Vascular, Inc.
Apr 11, 2025 Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-... During internal product testing, it was observed that some packages to have incomplete seals (ste... Class II LeMaitre Vascular, Inc.
Apr 10, 2025 CMS8000 Patient Monitor Patient monitor has nine identified cybersecurity vulnerabilities. Class II Contec Medical Systems Co., 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 9, 2025 PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acousti... The high voltage capacitor may fail early in the product life cycle after delivery of surge volta... Class II Richard Wolf GmbH
Apr 9, 2025 Centurion Sterile Weitlaner Retractor, Reorder: 67315 Three is the potential for the retractors to puncture through the sterile packaging. Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 9, 2025 FoundationOne Companion Diagnostic (F1CDx) Four (4) total reports were sent to customers with clinically relevant variants requiring amendme... Class II Foundation Medicine, Inc.
Apr 9, 2025 Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395 Three is the potential for the retractors to puncture through the sterile packaging. Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2025 REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487;... Due to a software issue, the software may incorrectly process the date of birth (DoB) received fr... Class II Beckman Coulter Inc.
Apr 8, 2025 Artix MT Thrombectomy Device, REF: 32-102 Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for... Class II Inari Medical - Oak Canyon
Apr 7, 2025 Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt... Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possi... Class II Philips North America Llc
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 7, 2025 Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US Incorrect labeling in which the front red pouch label did not match the actual size of the medica... Class II Ambu Inc.
Apr 7, 2025 Molding Equipment. WCM series. Model WCM-330GL-i Apic Yamada has recently discovered that certain products may be out of compliance with FDA elect... Class II Apic Yamada America
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 4, 2025 KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examinat... Potential for microbial contamination. Class II Klinika Mdical Gmb
Apr 4, 2025 Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro Supe... Preset treatment parameters are not consistently being used in accordance with the IFU. Class II Olympus Corporation of the Americas
Apr 4, 2025 INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation cath... Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton. Class II Integra LifeSciences Corp. (NeuroSciences)
Apr 4, 2025 KliniTray. KlinioTray. Tissue resection margin examination board/small. Model... Potential for microbial contamination. Class II Klinika Mdical Gmb
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 MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; Devices for the affected lot were not assembled according to product specifications. The distrac... Class II Globus Medical, Inc.
Apr 3, 2025 Enhanced Verify Evaluation Handset (CFN HH90130FA) Evaluation handsets may not be able to communicate with the neurostimulator due to handsets havin... Class II Medtronic Neuromodulation
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 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 2, 2025 Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat... Due to manufacturing issues, abutment products were manufactured with screw seat located too high... Class II Preat Corp
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 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 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
Apr 1, 2025 Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomogr... Unintended motion issues related to Interventional Control that may lead to collision of the Gant... Class II Philips North America Llc
Mar 31, 2025 Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Mod... During routine preventative maintenance checks, it was revealed that carbon filter sensors were b... Class II Ultra Clean Systems, Inc.
Mar 31, 2025 Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit An issue with a raw material used to coat some surgical needles that may result in diminished per... Class II AVID Medical, Inc.
Mar 31, 2025 Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit. An issue with a raw material used to coat some surgical needles that may result in diminished per... Class II AVID Medical, Inc.
Mar 31, 2025 Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, singl... Potential crack in the female connector located on the Heat Exchanger in the set, which will lead... Class II Belmont Instrument LLC
Mar 31, 2025 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/... Potential crack in the female connector located on the Heat Exchanger/patient line set, which wil... Class II Belmont Instrument LLC
Mar 31, 2025 Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. St... Potential crack in the female connector located on the Heat Exchanger in the set, which will lead... Class II Belmont Instrument LLC

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.