Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls.

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DateProductReasonClassFirm
Mar 1, 2017 Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Co... Class II Roche Diagnostics Corporation
Mar 1, 2017 Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx "Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the C... Class II Roche Diagnostics Corporation
Feb 27, 2017 Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim... Software issue. The difference between the display and dosimeter readings In the Child/Pediatric... Class II LIEBEL-FLARSHEIM COMPANY LLC
Feb 27, 2017 Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim ur... Software issue. The difference between the display and dosimeter readings In the Child/Pediatric... Class II LIEBEL-FLARSHEIM COMPANY LLC
Feb 27, 2017 MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning ... Unapproved change made by the supplier. Class II Zimmer Biomet, Inc.
Feb 23, 2017 Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems i... Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with... Class II Philips Medical Systems (Cleveland) Inc
Feb 20, 2017 Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza ... Software updates Class II Siemens Medical Solutions USA, Inc
Feb 15, 2017 Prismaflex Control Unit. Dialyzer, high permeability with or without sealed ... Firm has received reports of device operators failing to adhere to instructions for use pertainin... Class II Baxter Healthcare Corporation
Feb 14, 2017 ARTISTE" MV System Software update Class II Siemens Medical Solutions USA, Inc
Feb 14, 2017 Mevatron M2/Primus Mid-Energy PRIMUS HI Software update Class II Siemens Medical Solutions USA, Inc
Feb 14, 2017 ONCOR" Expression ONCOR" Impression ONCOR" Impression plus Software update Class II Siemens Medical Solutions USA, Inc
Feb 14, 2017 ONCOR" Avant-garde Software update Class II Siemens Medical Solutions USA, Inc
Feb 2, 2017 ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V... Multiple software issues, which may affect the operation and workflow of the system. Potential fo... Class II Siemens Healthcare Diagnostics, Inc.
Feb 1, 2017 Final Fit Software Version 1.11 and 1.12; PC Based software installed outsi... During treatment planning, the procedure was programmed with an unintended (wrong) correction. Class II Nidek Inc
Feb 1, 2017 Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ven... The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor ... Class II Respironics California Inc
Jan 31, 2017 MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and bel... Medtronic has identified a software anomaly that can prevent the internal battery of the pump fro... Class II Medtronic Inc.
Jan 26, 2017 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product... SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly tha... Class II Baxter Healthcare Corporation
Jan 23, 2017 Merge LIS A defect in the software resulted in medications that are not associated with the patient (i.e., ... Class II Merge Healthcare, Inc.
Jan 18, 2017 Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation ... An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software pro... Class II RAYSEARCH LABORATORIES AB
Jan 14, 2017 MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated B... Indications for use are not cleared or approved for market in the U.S. Class II Med-Hot Thermal Imaging, Inc.
Jan 11, 2017 Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quanti... Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read ... Class II Ortho Kinematics, Inc
Jan 11, 2017 VIDAS 3 software v. 1.1.4 During development of the VIDAS 3 software version 1.2, some anomalies have been identified and o... Class II BioMerieux SA
Jan 11, 2017 Syngo.plaza, picture archiving and communications system. Software update for improvements and to resolve several issues Class II Siemens Medical Solutions USA, Inc
Jan 11, 2017 Mammomat Inspiration full, field digital,system,x-ray,mammographic Product... Software error Class II Siemens Medical Solutions USA, Inc
Jan 5, 2017 EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra O... There is a possibility for data to be stored under the wrong patient on the DICOM Server followin... Class II Haag-Streit USA Inc
Dec 30, 2016 Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable ... Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops,... Class II Hospira Inc., A Pfizer Company
Dec 23, 2016 Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiati... Cross profile for Varian 60 degree wedge shows "horns." Class II Elekta, Inc.
Dec 22, 2016 IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database an... A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV ... Class II AGFA Healthcare Corp.
Dec 22, 2016 Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reportin... Power outages causes reporting software to shutdown. Class II Tosoh Smd Inc
Dec 21, 2016 AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number:... AutoDELFIA System with Version 3.0 Software: Potential plate loading failures Class III PerkinElmer Health Sciences, Inc.
Dec 21, 2016 DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number... AutoDELFIA System with Version 3.0 Software: Potential plate loading failures Class III PerkinElmer Health Sciences, Inc.
Dec 21, 2016 Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Produc... AutoDELFIA System with Version 3.0 Software: Potential plate loading failures Class III PerkinElmer Health Sciences, Inc.
Dec 21, 2016 Agfa Healthcare NX 3.0.8950 Imaging Processing Software A customer reported that when using an NX workstation with software version NX 3.0.8950 software ... Class II AGFA Healthcare Corp.
Dec 20, 2016 Accu-Chek Connect Diabetes Management App iOS and Android: Under certain conditions the affected app versions may disregard historical bolu... Class II Roche Diabetes Care, Inc.
Dec 16, 2016 IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spec... Multiple issues have caused the device to result in CT rescans or incorrect scan location or misr... Class II Philips Medical Systems (Cleveland) Inc
Dec 16, 2016 Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version N... A software error caused the window/level to become the same in one series regardless if the image... Class II DICOM GRID INC
Dec 13, 2016 Proteus 235, Proton Therapy System Product Usage: The Proton Therapy Syst... Software issue Class II Ion Beam Applications S.A.
Dec 8, 2016 Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis syst... Siemens initiated a corrective action to address two possible, mutually independent causes of a s... Class II Siemens Medical Solutions USA, Inc
Dec 8, 2016 Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis sys... Siemens initiated a corrective action to address two possible, mutually independent causes of a s... Class II Siemens Medical Solutions USA, Inc
Dec 2, 2016 Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056 A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 ReliOn FastA1C Test, Software Version Revision D, REF Number 3055 A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 A1CNow+ Systems (professional use product), Software Version Revision D, REF ... A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, ... A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 1, 2016 Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Softwar... Issue may cause eReports to consume an excessive amount of disk space causing the software to sto... Class II PerkinElmer Health Sciences, Inc.
Nov 29, 2016 CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The C... There is a remote possibility CentraLink may download an order to the ADVIA Automation System wit... Class II Siemens Healthcare Diagnostics, Inc.
Nov 23, 2016 AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335... Design error when displaying additional information in the patient view window; error may result ... Class II Radiometer America Inc
Nov 22, 2016 CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/... Accuray has become aware of a potential safety issue involving unexpected treatment robot motion ... Class II Accuray Incorporated
Nov 21, 2016 Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738... Software error; Carestream Health Inc, received a complaint stating that when a user accidentally... Class II Carestream Health Inc
Nov 15, 2016 SOMATOM Definition Flash System, x-ray, tomography, computed Intended to pro... Software update that provides software and firmware bug-fixes to improve system performance Class II Siemens Medical Solutions USA, 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.