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
Mar 19, 2025	epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens M...	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: Quantum Informatics - VIPER Product Name: Monitor, Physiological...	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.
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 18, 2025	Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:...	When expired reagents are scanned or manually entered, the system will change the expiration date...	Class II	Abbott Laboratories
Mar 18, 2025	Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:...	When expired reagents are scanned or manually entered, the system will change the expiration date...	Class II	Abbott Laboratories
Mar 18, 2025	Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:...	When expired reagents are scanned or manually entered, the system will change the expiration date...	Class II	Abbott Laboratories
Mar 18, 2025	Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:...	When expired reagents are scanned or manually entered, the system will change the expiration date...	Class II	Abbott Laboratories
Mar 18, 2025	Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:...	When expired reagents are scanned or manually entered, the system will change the expiration date...	Class II	Abbott Laboratories
Mar 17, 2025	DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ...	The reason for the recall is incorrect sample barcode identification and processing errors that r...	Class II	Beckman Coulter Inc.
Mar 12, 2025	Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Numb...	The potential for cracks forming in the breathing circuit hose.	Class I	Draeger, Inc.
Mar 12, 2025	Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...	The potential for cracks forming in the breathing circuit hose.	Class I	Draeger, Inc.
Mar 12, 2025	Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...	The potential for cracks forming in the breathing circuit hose.	Class I	Draeger, Inc.
Mar 12, 2025	Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...	The potential for cracks forming in the breathing circuit hose.	Class I	Draeger, Inc.
Mar 12, 2025	Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...	The potential for cracks forming in the breathing circuit hose.	Class I	Draeger, Inc.
Mar 12, 2025	Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Refe...	Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test r...	Class II	Qiagen Sciences LLC
Mar 12, 2025	Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...	The potential for cracks forming in the breathing circuit hose.	Class I	Draeger, Inc.
Mar 12, 2025	Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: ...	The potential for cracks forming in the breathing circuit hose.	Class I	Draeger, Inc.
Mar 11, 2025	BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-...	Users trying to restock a single bin location of an automated dispensing cabinet, during pocket e...	Class II	CareFusion 303, Inc.
Mar 11, 2025	BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYX...	Due to a software issue, when attempting to restock the automated dispensing cabinet, user have r...	Class II	CareFusion 303, Inc.
Mar 11, 2025	Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN):...	Incorrect software flagging may occur for the assay that may potentially lead to an erroneous res...	Class II	Siemens Healthcare Diagnostics, Inc.
Mar 11, 2025	BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD P...	Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancie...	Class II	CareFusion 303, Inc.
Mar 10, 2025	NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; ...	Nerve Monitoring System with certain software versions has potential for increased stimulus artif...	Class II	Medtronic Xomed, Inc.
Mar 5, 2025	stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, pack...	Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R...	Class II	Tornier S.A.S.
Mar 5, 2025	stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Art...	Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R...	Class II	Tornier S.A.S.
Mar 5, 2025	stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE20...	Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R...	Class II	Tornier S.A.S.
Mar 5, 2025	stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Ste...	Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R...	Class II	Tornier S.A.S.
Mar 5, 2025	stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in...	Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R...	Class II	Tornier S.A.S.
Mar 5, 2025	stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total...	Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R...	Class II	Tornier S.A.S.
Mar 5, 2025	stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total...	Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R...	Class II	Tornier S.A.S.
Mar 5, 2025	stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, pa...	Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R...	Class II	Tornier S.A.S.
Mar 5, 2025	stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packa...	Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R...	Class II	Tornier S.A.S.
Mar 4, 2025	Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Mod...	The impacted lots have a higher occurrence of invalid rates when compared to the product Instruct...	Class II	Abbott Diagnostics Scarborough, Inc.
Mar 4, 2025	Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number:...	The impacted lots have a higher occurrence of invalid rates when compared to the product Instruct...	Class II	Abbott Diagnostics Scarborough, Inc.
Mar 4, 2025	Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT P...	AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compre...	Class I	ZOLL Circulation, Inc.
Mar 4, 2025	Stimulation RC Clinician Programmer Application, Model A71400, when used with...	There is a software issue that can permanently disable communication with an implantable neurosti...	Class II	Medtronic Neuromodulation
Mar 4, 2025	Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Mod...	the impacted lots have a higher occurrence of invalid rates when compared to the product Instruct...	Class II	Abbott Diagnostics Scarborough, Inc.
Mar 4, 2025	Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 2...	The impacted lots have a higher occurrence of invalid rates when compared to the product Instruct...	Class II	Abbott Diagnostics Scarborough, Inc.
Mar 4, 2025	Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number:...	the impacted lots have a higher occurrence of invalid rates when compared to the product Instruct...	Class II	Abbott Diagnostics Scarborough, Inc.
Mar 4, 2025	Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 2...	the impacted lots have a higher occurrence of invalid rates when compared to the product Instruct...	Class II	Abbott Diagnostics Scarborough, Inc.
Feb 28, 2025	Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;	Multiple problems identified with the software version leading to various scanning and image issu...	Class II	Philips Medical Systems Nederland B.V.
Feb 27, 2025	Tandem Mobi Insulin Pump with Interoperable Technology	A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,...	Class I	Tandem Diabetes Care, Inc.
Feb 27, 2025	t:slim X2 Insulin Pump with Interoperable Technology	A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,...	Class I	Tandem Diabetes Care, Inc.
Feb 26, 2025	DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ...	Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. ...	Class II	Beckman Coulter Inc.
Feb 26, 2025	Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedal...	Due to an increase in complaints concerning foot tray pedal spring failing resulting in the ped...	Class II	Intuitive Surgical, Inc.
Feb 25, 2025	Baxter Mobile column TruSystem 7500, Product Code 1717023	There is a software issue which causes the upper back section to not be operable/adjustable when ...	Class II	Baxter Healthcare Corporation
Feb 25, 2025	Baxter Floor mounting column TS 7500 U, Product Code 1730732	There is a software issue which causes the upper back section to not be operable/adjustable when ...	Class II	Baxter Healthcare Corporation
Feb 25, 2025	Baxter Floor mounting column TruSystem 7500, Product Code 1717021	There is a software issue which causes the upper back section to not be operable/adjustable when ...	Class II	Baxter Healthcare Corporation
Feb 25, 2025	Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088	There is a software issue which causes the upper back section to not be operable/adjustable when ...	Class II	Baxter Healthcare Corporation

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.