Browse Device Recalls

3,007 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,007 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 3,007 FDA device recalls.

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DateProductReasonClassFirm
Jun 19, 2019 iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 Potential for iGUIDE to incorrectly monitor the 3D position. Class II Elekta, Inc.
Jun 10, 2019 Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usa... Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci seri... Class II Abbott Gmbh & Co. KG
Jun 4, 2019 SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, ... The potential sporadic performance problems may cause scanning workflow interruptions and unexp... Class II Siemens Medical Solutions USA, Inc
Jun 4, 2019 SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, ... The potential sporadic performance problems may cause scanning workflow interruptions and unexp... Class II Siemens Medical Solutions USA, Inc
Jun 4, 2019 SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, ... The potential sporadic performance problems may cause scanning workflow interruptions and unexp... Class II Siemens Medical Solutions USA, Inc
Jun 4, 2019 SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, ... The potential sporadic performance problems may cause scanning workflow interruptions and unexp... Class II Siemens Medical Solutions USA, Inc
May 28, 2019 SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20... The potential sporadic performance problems may result in scanning workflow interruptions and une... Class II Siemens Medical Solutions USA, Inc
May 28, 2019 SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A... The potential sporadic performance problems may result in scanning workflow interruptions and une... Class II Siemens Medical Solutions USA, Inc
May 28, 2019 SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20... The potential sporadic performance problems may result in scanning workflow interruptions and une... Class II Siemens Medical Solutions USA, Inc
May 28, 2019 SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_... The potential sporadic performance problems may result in scanning workflow interruptions and une... Class II Siemens Medical Solutions USA, Inc
May 23, 2019 Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software v... During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscr... Class II Obalon Therapeutics Inc
May 21, 2019 The Alinity ci-series System Control Modules which are configured with Alinit... All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrate... Class II Abbott Gmbh & Co. KG
May 20, 2019 Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used... Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad o... Class II Medtronic Inc.
May 20, 2019 The Visibly Online Refractive Vision Test which is part of the Visibly Vision... Lack of 510K clearance Class II Opternative Inc
May 17, 2019 Beckman Coulter Power Express Sample Processing System AU5800XL connection un... Potential exposure to biohazard. Software design problem causes excess speed and vibrations in... Class II Beckman Coulter Inc.
May 16, 2019 Centricity PACS Foundation Centricity PACS software product is intended fo... There is the possibility of viewing studies directly from the Enterprise Archive or VNA with inco... Class II GE Healthcare, LLC
May 3, 2019 AUTION HYBRID AU-4050 This correction is being initiated due to a software issue which results in the possibility of in... Class II Arkray Factory USA, Inc.
Apr 29, 2019 Philips Patient Information Center iX configured with a regional setting whic... Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion ... Class III Philips North America, LLC
Apr 29, 2019 Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Model... There is a potential that the image of one patient could get unexpectedly moved into another pati... Class II Philips Ultrasound Inc
Apr 19, 2019 SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiolog... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 19, 2019 SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological p... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 19, 2019 SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the phys... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 19, 2019 SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the p... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 19, 2019 SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiolog... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 19, 2019 SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring th... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 19, 2019 SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the phy... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 19, 2019 SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiologi... System software inhibits the monitor and as a result does not measure, display and alarm for puls... Class II Philips North America, LLC
Apr 17, 2019 AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Appli... Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Apr 17, 2019 AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero G... Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Apr 17, 2019 AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Appli... Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Apr 17, 2019 AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Appl... Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Apr 17, 2019 AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generat... Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Apr 15, 2019 PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Posi... Class II Hitachi America, Ltd., Power Systems Division
Apr 5, 2019 TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 P... In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version ... Class II Abbott Laboratories Inc. (St Jude Medical)
Apr 4, 2019 SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085... The manufacturer received complaints that customers were attempting to install the fitting softwa... Class III Advanced Bionics, LLC
Apr 3, 2019 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 1... Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72. Class III Fresenius Medical Care Renal Therapies Group, LLC
Apr 1, 2019 da Vinci SP surgical system Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the ... Class II Intuitive Surgical, Inc.
Mar 25, 2019 HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTO... New software version for affected ventilators reduces the probability of the ventilator entering ... Class I Hamilton Medical AG
Mar 22, 2019 Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200... Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radia... Class II Siemens Medical Solutions USA, Inc
Mar 21, 2019 syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: ... There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning proc... Class II Siemens Medical Solutions USA, Inc
Mar 21, 2019 Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal in... The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
Mar 21, 2019 syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: ... There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning proc... Class II Siemens Medical Solutions USA, Inc
Mar 21, 2019 Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion. The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
Mar 21, 2019 Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, u... The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
Mar 21, 2019 Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No... The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
Mar 21, 2019 Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion. The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
Mar 20, 2019 Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/... Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP functio... Class II Siemens Medical Solutions USA, Inc
Mar 15, 2019 Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of ... Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherich... Class II bioMerieux, Inc.
Mar 12, 2019 Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta... Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The... Class II Elekta Limited
Mar 11, 2019 RT Elements Software revisions of the RT Elements applications have a speci... There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements softw... Class II Brainlab AG

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.