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
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Nov 28, 2025	RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStatio...	Potential for the invalidation for calculated radiation dose does not work as intended for certai...	Class II	RAYSEARCH LABORATORIES AB
Nov 28, 2025	Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe...	Potential for the invalidation for calculated radiation dose does not work as intended for certai...	Class II	RAYSEARCH LABORATORIES AB
Nov 28, 2025	RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. S...	Potential for the invalidation for calculated radiation dose does not work as intended for certai...	Class II	RAYSEARCH LABORATORIES AB
Nov 28, 2025	Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe...	Potential for the invalidation for calculated radiation dose does not work as intended for certai...	Class II	RAYSEARCH LABORATORIES AB
Nov 28, 2025	RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12...	Potential for the invalidation for calculated radiation dose does not work as intended for certai...	Class II	RAYSEARCH LABORATORIES AB
Nov 28, 2025	Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe...	Potential for the invalidation for calculated radiation dose does not work as intended for certai...	Class II	RAYSEARCH LABORATORIES AB
Nov 28, 2025	Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe...	Potential for the invalidation for calculated radiation dose does not work as intended for certai...	Class II	RAYSEARCH LABORATORIES AB
Nov 28, 2025	Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe...	Potential for the invalidation for calculated radiation dose does not work as intended for certai...	Class II	RAYSEARCH LABORATORIES AB
Nov 28, 2025	Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe...	Potential for the invalidation for calculated radiation dose does not work as intended for certai...	Class II	RAYSEARCH LABORATORIES AB
Nov 24, 2025	Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog...	Ophthalmic procedure packs may have incomplete seals affecting sterility.	Class I	Alcon Research LLC
Nov 24, 2025	LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software...	Software issue only allows Concentration Limits to be defined to one digit of precision past the ...	Class II	ICU Medical, Inc.
Nov 24, 2025	LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Softwar...	For certain customers, the Change Summary review option ceases to operate as expected for any mig...	Class II	ICU Medical, Inc.
Nov 21, 2025	Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.	Emphasizing instructions for LVP duration programming located in the IFU.	Class II	Fresenius Kabi USA, LLC
Nov 20, 2025	Restore Clinician Programmer Application (CP App), Model A71100 used with the...	Software issue where a Device Reset message displayed on the app was unable to be cleared. In rar...	Class II	Medtronic Neuromodulation
Nov 20, 2025	BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliar...	Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which ca...	Class II	CareFusion 303, Inc.
Nov 18, 2025	Intelerad InteleShare software, with ProViewer component	Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical st...	Class II	DICOM Grid, Inc.
Nov 18, 2025	Hardware configuration of the BeneVision Central Monitoring System (CMS), mar...	When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may...	Class II	Mindray DS USA, Inc. dba Mindray North America
Nov 17, 2025	Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used...	An error event following the release of a software version for the surgical system that can resul...	Class II	Intuitive Surgical, Inc.
Nov 14, 2025	Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the cont...	Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious pa...	Class I	Fresenius Kabi USA, LLC
Nov 13, 2025	InPen App, Model/CFN Number: MMT-8061 (Android Users)	When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification St...	Class II	Medtronic MiniMed, Inc.
Nov 13, 2025	Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20	Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immun...	Class II	Abbott Laboratories
Nov 12, 2025	The Stryker CranialMask Tracker is a single-use device consisting of a flexib...	When the device is activated during surgery, the device software issues an error message "Instrum...	Class II	Howmedica Osteonics Corp.
Nov 7, 2025	Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vin...	Due to a software implementation error that allowed instruments arms failing an important diagnos...	Class II	Intuitive Surgical, Inc.
Nov 7, 2025	Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety ...	IFU and device kit labeling contains misleading statements leading to improper securing of the de...	Class II	Rocket Medical Plc
Nov 7, 2025	Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tr...	IFU and device kit labeling contains misleading statements leading to improper securing of the de...	Class II	Rocket Medical Plc
Nov 7, 2025	Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety ...	IFU and device kit labeling contains misleading statements leading to improper securing of the de...	Class II	Rocket Medical Plc
Nov 7, 2025	Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tr...	IFU and device kit labeling contains misleading statements leading to improper securing of the de...	Class II	Rocket Medical Plc
Nov 7, 2025	Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tr...	IFU and device kit labeling contains misleading statements leading to improper securing of the de...	Class II	Rocket Medical Plc
Nov 6, 2025	BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD Alar...	Due to a number of modules flashed with a date and time associated with the daylight savings time...	Class II	CareFusion 303, Inc.
Nov 3, 2025	GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image proces...	GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6....	Class II	GE Healthcare GmbH
Nov 2, 2025	MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software...	A software timing and processor communication issue in MiniMed" 780G software version 6.60 may tr...	Class II	Medtronic MiniMed, Inc.
Oct 29, 2025	Incisive CT; Software Version Number: 4.5, 5.0, 5.1;	If the screws of tube heat exchanger on the rotating scanner are not tightened well after replaci...	Class II	Philips North America Llc
Oct 29, 2025	CT 5300; Software Version Number: 4.5, 5.0, 5.1;	If the screws of tube heat exchanger on the rotating scanner are not tightened well after replaci...	Class II	Philips North America Llc
Oct 25, 2025	5008X CAREsystem +CLiC +CDX;	Several software anomalies with the potential to impact patient treatment, of which one includes ...	Class II	Fresenius Medical Care Holdings, Inc.
Oct 24, 2025	Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, i...	As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot...	Class II	Edan Diagnostics
Oct 24, 2025	Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Numb...	As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot...	Class II	Edan Diagnostics

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.