Browse Device Recalls

3,089 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,089 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 3,089 FDA device recalls.

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DateProductReasonClassFirm
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
Oct 21, 2025 CareLink Clinic, REF: MMT-7350 Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Grap... Class II Medtronic MiniMed, Inc.
Oct 17, 2025 IntelePACS - InteleConnect / TechPortal Software application that receives digital images and data to be communicated, processed, manipul... Class II INTELERAD MEDICAL SYSTEMS INCORPORATED
Oct 13, 2025 DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Softwar... Potential for device to not meet specifications resulting in incorrect results or delay of referr... Class II DERMASENSOR INC
Oct 9, 2025 Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Numbe... Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed fo... Class II C-RAD POSITIONING AB
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Ca... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) M... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Mod... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
Oct 8, 2025 Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CAT... Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility... Class II Sterilmed, Inc.
Oct 8, 2025 Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WIT... Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility... Class II Sterilmed, Inc.
Oct 6, 2025 Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are batt... Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or ma... Class I Tandem Diabetes Care, Inc.
Oct 1, 2025 Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immu... Due to distributing the measles IgG IVD without a premarket approved/cleared. Class II Quest International, Inc.
Sep 30, 2025 Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereo... Due to increased risk that paint flakes from the engravings may separate from the device and ther... Class II Elekta, Inc.
Sep 30, 2025 Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET F... The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damag... Class I B BRAUN MEDICAL INC
Sep 26, 2025 Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model... Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening ... Class II Medistim Asa
Sep 25, 2025 Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Ve... Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... Class II PHILIPS MEDICAL SYSTEMS
Sep 25, 2025 Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast ... Due to an identified manufacturing defect involving coating material lifting within the catheter'... Class I BALT USA, LLC
Sep 25, 2025 Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.... Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... Class II PHILIPS MEDICAL SYSTEMS

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.