Browse Device Recalls

2,601 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,601 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 2,601 FDA device recalls in 2023.

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Date	Product	Reason	Class	Firm
Nov 29, 2023	Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V...	During an internal investigation, ACS identified that several components were "piggybacked" to AC...	Class II	American Contract Systems, Inc.
Nov 29, 2023	Sensis Vibe Hemo	The possibility of the Sensis documentation functionality application to crash.	Class II	Siemens Medical Solutions USA, Inc
Nov 29, 2023	Ivenix Infusion System (IIS), Large Volume Pump LVP-0004	The device may experience mechanical interference on the Fluid Valve pins, which will trigger a P...	Class I	Fresenius Kabi USA, LLC
Nov 28, 2023	MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femor...	Cordis became aware that the label for the carton box containing 10 units is incorrect for some b...	Class II	Cordis US Corp
Nov 28, 2023	(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436	Push notifications may fail to send to the user under certain conditions. This could potentially ...	Class II	Philips North America
Nov 28, 2023	VADER pedicle system, torque wrench, Catalog Number 42-703	icotec has received notification of one revision that had to be carried out because nut screws ha...	Class II	Icotec Ag
Nov 28, 2023	External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only	Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburd...	Class II	Natus Medical Incorporated
Nov 28, 2023	EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only	Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburd...	Class II	Natus Medical Incorporated
Nov 28, 2023	(1) Patient Information Center iX, Model No. 866389 (2) Patient Information ...	Push notifications may fail to send to the user under certain conditions. This could potentially ...	Class II	Philips North America
Nov 28, 2023	Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS	Their is the potential that the percutaneous pin may have a cross-pin that may render the pin una...	Class II	Medtronic Navigation, Inc.
Nov 28, 2023	Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056	AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provide...	Class II	AtriCure, Inc.
Nov 28, 2023	MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral ...	Cordis became aware that the label for the carton box containing 10 units is incorrect for some b...	Class II	Cordis US Corp
Nov 28, 2023	Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S,...	Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop ou...	Class II	TriMed Inc.
Nov 28, 2023	Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS	Their is the potential that the percutaneous pin may have a cross-pin that may render the pin una...	Class II	Medtronic Navigation, Inc.
Nov 28, 2023	Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws lab...	Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorr...	Class II	XTANT Medical Holdings, Inc
Nov 28, 2023	VADER pedicle system, torque wrench, Catalog Number 42-702	icotec has received notification of one revision that had to be carried out because nut screws ha...	Class II	Icotec Ag
Nov 28, 2023	Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053	AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provide...	Class II	AtriCure, Inc.
Nov 28, 2023	Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to...	In rare cases, the lever of the throttle can get temporarily stuck during the movement and does n...	Class II	mo-Vis BVBA
Nov 28, 2023	MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray Sy...	Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the o...	Class II	Micro-X Ltd.
Nov 27, 2023	Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA21...	The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is cont...	Class II	Philips Respironics, Inc.
Nov 27, 2023	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nu...	A manufacturing event may contribute to elevated rates of false negative results while using gast...	Class II	BioFire Diagnostics, LLC
Nov 27, 2023	Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear M...	Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall dow...	Class II	Mirion Technologies (Capintec), Inc.
Nov 27, 2023	VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog ...	Affected lots may experience increased calibration failures or an increase in falsely elevated re...	Class II	Ortho-Clinical Diagnostics, Inc.
Nov 27, 2023	The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic ...	A manufacturing event may contribute to elevated rates of false negative results while using gast...	Class II	BioFire Diagnostics, LLC
Nov 27, 2023	RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 Th...	Due to potential breakage during use.	Class II	Acumed LLC
Nov 23, 2023	The device is a mobile x-ray system designed to work with Fujifilm's GOS and ...	When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1....	Class II	FUJIFILM Healthcare Americas Corporation
Nov 23, 2023	Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rup...	Interference testing has shown that the presence of personal lubricants in the vaginal specimen c...	Class II	ACTIM OY
Nov 22, 2023	DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572	Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure tran...	Class II	DeRoyal Industries Inc
Nov 21, 2023	Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va...	Class II	Exactech, Inc.
Nov 21, 2023	Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, ...	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va...	Class II	Exactech, Inc.
Nov 21, 2023	Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41...	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va...	Class II	Exactech, Inc.
Nov 21, 2023	Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-00...	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va...	Class II	Exactech, Inc.
Nov 21, 2023	DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,	There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, includi...	Class II	Beckman Coulter, Inc.
Nov 21, 2023	Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02...	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va...	Class II	Exactech, Inc.
Nov 21, 2023	Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-...	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va...	Class II	Exactech, Inc.
Nov 21, 2023	Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01...	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va...	Class II	Exactech, Inc.
Nov 21, 2023	Exactech Novation Hip System, Catalog Numbers: 134-36-45	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va...	Class II	Exactech, Inc.
Nov 21, 2023	Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va...	Class II	Exactech, Inc.
Nov 21, 2023	Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, ...	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va...	Class II	Exactech, Inc.
Nov 21, 2023	Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314...	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va...	Class II	Exactech, Inc.
Nov 21, 2023	AcuMatch Hip System, Catalog Number 142-32-27	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va...	Class II	Exactech, Inc.
Nov 21, 2023	QMS Tacrolimus Calibrators, Product code 10015573	Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry dat...	Class II	Ortho-Clinical Diagnostics, Inc.
Nov 21, 2023	Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay An...	There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with t...	Class II	Beckman Coulter, Inc.
Nov 20, 2023	AirFit N20 Nasal Mask and User Guide	Masks non-invasive interface for channeling airflow to patients have magnets that have potential ...	Class I	ResMed Ltd.
Nov 20, 2023	AirFit F30i Full Face Mask and User Guide	Masks non-invasive interface for channeling airflow to patients have magnets that have potential ...	Class I	ResMed Ltd.
Nov 20, 2023	AirFit F20 Full Face Mask and User Guide	Masks non-invasive interface for channeling airflow to patients have magnets that have potential ...	Class I	ResMed Ltd.
Nov 20, 2023	OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S1...	Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in t...	Class II	Olympus Corporation of the Americas
Nov 20, 2023	NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) P...	One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of in...	Class II	THOR Photomedicine Ltd
Nov 20, 2023	Calibration Serum Level 3 CAL2351	CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series inst...	Class II	Randox Laboratories Ltd.
Nov 20, 2023	AirFit N10 Nasal Masks and User Guide	Masks non-invasive interface for channeling airflow to patients have magnets that have potential ...	Class I	ResMed Ltd.

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.