Browse Device Recalls

2,945 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,945 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 2,945 FDA device recalls.

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Date	Product	Reason	Class	Firm
May 8, 2025	BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 400...	Antivirus software was not consistently installed on impacted devices during the implementation p...	Class II	CareFusion 303, Inc.
May 8, 2025	Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD P...	During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in...	Class II	CareFusion 303, Inc.
May 7, 2025	Z-800F Infusion System. Intended to provide intravenous infusion of parentera...	Unreleased software versions were installed on distributed devices without verification or valida...	Class I	Zyno Medical LLC
May 7, 2025	Z-800W Infusion System. Intended to provide intravenous infusion of parentera...	Unreleased software versions were installed on distributed devices without verification or valida...	Class I	Zyno Medical LLC
May 7, 2025	Z-800WF Infusion System. Intended to provide intravenous infusion of parenter...	Unreleased software versions were installed on distributed devices without verification or valida...	Class I	Zyno Medical LLC
May 7, 2025	Z-800 Infusion System. Intended to provide intravenous infusion of parenteral...	Unreleased software versions were installed on distributed devices without verification or valida...	Class I	Zyno Medical LLC
May 7, 2025	Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM0000...	Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ...	Class II	Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
May 6, 2025	Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium ...	Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or u...	Class II	Olympus Corporation of the Americas
May 6, 2025	PhenoMATRIX	AI-powered bacterial culture plate interpretation and workup software does not have Premarket App...	Class II	Copan WASP
May 2, 2025	LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software...	Firm has identified Drug Library Management defects in the software: 1) DLM software does not all...	Class II	ICU Medical, Inc.
Apr 28, 2025	Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog...	Due to the potential that some units within specific lots were damaged during the manufacturing p...	Class II	Alcon Research LLC
Apr 28, 2025	Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision Syst...	Due to the potential that some units within specific lots were damaged during the manufacturing p...	Class II	Alcon Research LLC
Apr 28, 2025	Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision Syst...	Due to the potential that some units within specific lots were damaged during the manufacturing p...	Class II	Alcon Research LLC
Apr 25, 2025	Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Cat...	Sterility assurance for Ophthalmic knives.	Class II	Tecfen Medical
Apr 25, 2025	Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Cat...	Sterility assurance for Ophthalmic knives.	Class II	Tecfen Medical
Apr 25, 2025	Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Stra...	Sterility assurance for Ophthalmic knives.	Class II	Tecfen Medical
Apr 25, 2025	Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Cat...	Sterility assurance for Ophthalmic knives.	Class II	Tecfen Medical
Apr 25, 2025	Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog...	Sterility assurance for Ophthalmic knives.	Class II	Tecfen Medical
Apr 25, 2025	Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel U...	Sterility assurance for Ophthalmic knives.	Class II	Tecfen Medical
Apr 25, 2025	Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Cat...	Sterility assurance for Ophthalmic knives.	Class II	Tecfen Medical
Apr 24, 2025	iBOT PMD with software version 01.05.24. Personal Mobility Device.	Software issue that could potentially lead to the device tipping over from Balance Mode.	Class II	Mobius Mobility LLC
Apr 23, 2025	DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software...	A new motor/encoder and cable was introduced into instruments manufactured starting with serial n...	Class II	Beckman Coulter, Inc.
Apr 23, 2025	DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software...	A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assa...	Class II	Beckman Coulter, Inc.
Apr 23, 2025	MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical s...	The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have th...	Class II	VIRTUAL INCISION CORPORATION
Apr 22, 2025	ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400...	Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may r...	Class II	ICU Medical, Inc.
Apr 22, 2025	ICU Medical Plum Solos, Item number 400011001; infusion pump	Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may r...	Class II	ICU Medical, 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	Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/...	Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d...	Class I	Vyaire Medical
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 10, 2025	Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/...	Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d...	Class I	Vyaire Medical
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 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 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	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 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 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 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 20, 2025	DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ...	Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software erro...	Class II	Beckman Coulter Inc.
Mar 19, 2025	epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens ...	The occurrence of discrepant high pH results in samples introduced with higher injection volumes ...	Class II	Siemens Healthcare Diagnostics Inc
Mar 19, 2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu...	Lack of sterility assurance for closed suction catheter systems	Class I	Avanos Medical, Inc.
Mar 19, 2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu...	Lack of sterility assurance for closed suction catheter systems	Class I	Avanos Medical, Inc.
Mar 19, 2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu...	Lack of sterility assurance for closed suction catheter systems	Class I	Avanos Medical, Inc.
Mar 19, 2025	Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, P...	Medical device software marketed without FDA clearance .	Class II	Spectrum Medical Ltd.
Mar 19, 2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu...	Lack of sterility assurance for closed suction catheter systems	Class I	Avanos Medical, Inc.
Mar 19, 2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu...	Lack of sterility assurance for closed suction catheter systems	Class I	Avanos Medical, Inc.

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.