Browse Device Recalls

3,099 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,099 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 3,099 FDA device recalls.

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DateProductReasonClassFirm
May 6, 2014 Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; L... There is a potential risk when using LANTIS OIS System client software with operating systems for... Class II Siemens Medical Solutions USA, Inc
May 5, 2014 Horizon Medical Imaging It is a medical image and information management a... The firm has identified a software issue which may cause a discrepancy between the index of image... Class II Mckesson Medical Immaging
May 5, 2014 All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R... In spine clinical workflows, cross reference lines may be used to determine the position of slice... Class II Philips Medical Systems, Inc.
Apr 30, 2014 Merge Hemo software. Merge Hemo monitors, measures, and records physiolog... The application may crash during the cath lab procedure. Class II Merge Healthcare, Inc.
Apr 30, 2014 IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optic... Failure to effectively install and test a hotfix to correct the known software defect within the ... Class II AGFA Corp.
Apr 25, 2014 RayStation software version 4.0.3.4 RayStation is a software system design... This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT h... Class II RAYSEARCH LABORATORIES AB
Apr 23, 2014 Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits... CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software ... Class I CareFusion 303, Inc.
Apr 23, 2014 ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using S... Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software... Class II Siemens Medical Solutions USA, Inc.
Apr 23, 2014 ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasoun... Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly... Class II Siemens Medical Solutions USA, Inc.
Apr 22, 2014 HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anes... Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the ac... Class I Hamilton Medical, Inc.
Apr 17, 2014 enGen (TM) Laboratory Automation System Configured with TCAutomation" Softwar... Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Sys... Class II Ortho-Clinical Diagnostics
Apr 10, 2014 enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vit... Software anomaly: potential for delay in the reporting of patient sample test results when using ... Class II Ortho-Clinical Diagnostics
Apr 7, 2014 GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 ... GE Healthcare has recently become aware of a potential safety issue due to higher than actual flo... Class II GE Healthcare, LLC
Apr 3, 2014 iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ul... Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullb... Class II Boston Scientific Corporation
Apr 3, 2014 Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PA... Systems with the affected serial number are experiencing a software error which may lead to incor... Class II Siemens Medical Solutions USA, Inc
Apr 2, 2014 Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, ... When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are use... Class II Siemens Medical Solutions USA, Inc.
Apr 2, 2014 Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled... Medical device software may be defective and may cause user-set alarm limits to result in false p... Class II GE Healthcare
Apr 2, 2014 Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM pa... Medical device software may be defective and may cause user-set alarm limits to result in false p... Class II GE Healthcare
Apr 2, 2014 Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared ... Medical device software may be defective and may cause user-set alarm limits to result in false p... Class II GE Healthcare
Apr 2, 2014 Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controll... Medical device software may be defective and may cause user-set alarm limits to result in false p... Class II GE Healthcare
Apr 2, 2014 ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculat... 1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values durin... Class I Baxter Corporation Englewood
Apr 2, 2014 Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software appli... Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density ... Class II Philips Medical Systems, Inc.
Apr 2, 2014 Philips HeartStart XL+ Defibrillator/Monitor with system software version B.... Software communication failure may occur on the HeartStart XL+ locking the user out of clinical m... Class II Philips Medical Systems, Inc.
Apr 2, 2014 Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrar... Medical device software may be defective and may cause user-set alarm limits to result in false p... Class II GE Healthcare
Mar 27, 2014 INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version... An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrat... Class II INO Therapeutics (dba Ikaria)
Mar 20, 2014 enGen (TM) Laboratory Automation System configured with Data Innovations, LLC... Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires fol... Class II Ortho-Clinical Diagnostics
Mar 11, 2014 IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model ... During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Corr... Class II Philips Medical Systems (Cleveland) Inc
Mar 10, 2014 SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installe... The System may go into a controlled failed state if a series of parameters on the user interface ... Class I Del Mar Reynolds Medical, Ltd.
Mar 6, 2014 Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical System... A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions wo... Class II Philips Medical Systems (Cleveland) Inc
Mar 5, 2014 Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor W... Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used Class II ZOLL Medical Corporation
Feb 28, 2014 GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 C... GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE ... Class II GE Healthcare, LLC
Feb 27, 2014 Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including t... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 27, 2014 D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by:... On a rare occasion the D-10 software might generate an extra result by duplicating the result for... Class II Bio-Rad Laboratories, Inc.
Feb 24, 2014 ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalog... When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might ... Class II Brainlab AG
Feb 14, 2014 GE Healthcare Optima CT580/Discovery CT590RT scanners running software versio... GE Healthcare has recently become aware of a potential safety issue due to a software issue assoc... Class II GE Healthcare, LLC
Feb 14, 2014 Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Re... Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed ... Class II Spacelabs Healthcare, Llc
Feb 14, 2014 RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alon... RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software d... Class II RAYSEARCH LABORATORIES AB
Feb 14, 2014 ROSA Surgical Device 2.5.8. It is intended to be used in the operating ro... An undetected shift between the information displayed in the navigation software and the actual p... Class II Zimmer Biomet, Inc.
Feb 14, 2014 Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A ... HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) ... Class II Horiba Instruments, Inc dba Horiba Medical
Feb 13, 2014 GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.... GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patien... Class II GE Healthcare, LLC
Feb 12, 2014 CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog ... Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2... Class II Biosense Webster, Inc.
Feb 11, 2014 Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. Philips Medical Systems have recently determined that a software nonconformance can cause incorre... Class II Philips Medical Systems (Cleveland), Inc.
Feb 6, 2014 RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 ... Potential for dose errors due to software program errors. Class II RAYSEARCH LABORATORIES AB
Feb 6, 2014 RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alo... RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calcu... Class II RAYSEARCH LABORATORIES AB
Jan 24, 2014 RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medic... Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6... Class II Clarity Medical Systems Inc
Jan 20, 2014 GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital ... GE Healthcare has recently become aware of a software issue associated with patient selection fro... Class II GE Healthcare, LLC
Jan 8, 2014 CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRAC... Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿. Class II Veridex, LLC
Dec 27, 2013 GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARES... GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE ... Class II GE Healthcare, LLC
Dec 26, 2013 KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by... Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software ... Class II Carestream Health, Inc.
Dec 20, 2013 CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intende... There is a potential for communication loss associated with the F5-01 Frame when connected to CAR... Class II GE Healthcare, LLC

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.