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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.