Browse Device Recalls

39,949 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,949 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 39,949 FDA device recalls.

DateProductReasonClassFirm
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 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 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 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 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 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 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 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
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 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
Mar 31, 2025 Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Steri... 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 Halyard SUTURE PACK CABG. 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 Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparin... Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IV... Class II Siemens Healthcare Diagnostics 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 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 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 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 28, 2025 Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S; The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the ... Class II Stryker GmbH
Mar 28, 2025 Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S; The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the ... Class II Stryker GmbH
Mar 28, 2025 Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: M... Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load... Class II Micro-X Ltd.
Mar 28, 2025 Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: M... Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load... Class II Micro-X Ltd.
Mar 27, 2025 Beckman Coulter DxI 9000 Access Immunoassay Analyzer When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information s... Class II Beckman Coulter, Inc.
Mar 27, 2025 GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intende... Due to a potential open seal in the sterile barrier packaging . Class II Galt Medical Corporation
Mar 27, 2025 Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVist... In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjun... Class I Bausch & Lomb Surgical, Inc.
Mar 27, 2025 Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34... Due to a potential open seal in the sterile barrier packaging. Class II Galt Medical Corporation
Mar 27, 2025 Introducer Needle REF NDL-107-04 These needles are used for the percutane... Due to a potential open seal in the sterile barrier packaging. Class II Galt Medical Corporation
Mar 27, 2025 Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101... Due to a potential open seal in the sterile barrier packaging. Class II Galt Medical Corporation
Mar 27, 2025 Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Env... In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjun... Class I Bausch & Lomb Surgical, Inc.
Mar 27, 2025 B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 61280... Due to a potential open seal in the sterile barrier packaging . Class II Galt Medical Corporation
Mar 27, 2025 B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-0... Due to a potential open seal in the sterile barrier packaging . Class II Galt Medical Corporation
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 27, 2025 GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutan... Due to a potential open seal in the sterile barrier packaging. Class II Galt Medical Corporation
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 25, 2025 restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: H... The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 178... Class II Conformis Inc.
Mar 24, 2025 IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needl... Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... Class II Boston Scientific Corporation
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 8... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 8... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Intera CV, Model Number: 781107; The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 24, 2025 Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetell... It was determined that there could be a false positive rate of up to 16.7% for the affected lots ... Class II Ortho-Clinical Diagnostics, Inc.
Mar 24, 2025 Intera 1.0T Power/Pulsar, Model Number: 781103; The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 24, 2025 Intera 1.5T, Model Numbers: 781195 and 781295; The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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.