Browse Device Recalls
3,235 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,235 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 3,235 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Mar 11, 2019 | VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 ... | One of the software algorithms used to detect sample dispense errors was inadvertently disabled. ... | Class II | Ortho-Clinical Diagnostics |
| Mar 7, 2019 | Atellica IM 1300 Analyzer, Material Number 11066001 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2019 | Atellica Sample Handler Prime, Material Number 11069001 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2019 | Atellica IM 1600 Analyzer, Material Number 11066000 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2019 | Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R7... | Potential performance issues in the Alinity-ci software version 2.5.1 | Class II | Abbott Gmbh & Co. KG |
| Mar 6, 2019 | IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program t... | When a patient is selected in the patient data and another patient is selected prior to the displ... | Class II | Topcon Medical Systems, Inc. |
| Mar 5, 2019 | Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled ... | Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events invo... | Class II | Fenwal Inc |
| Mar 3, 2019 | MRIdian Linac Radiation Therapy System Model 10000 and 20000 | Issue with transferring treatment regiment from one system to another. Adequate instructions for... | Class II | Viewray, Inc. |
| Feb 27, 2019 | Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software ... | In certain occurrences, the affected navigation software application might unexpectedly display a... | Class I | Brainlab AG |
| Feb 21, 2019 | BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: B... | BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect c... | Class II | Becton Dickinson & Co. |
| Feb 20, 2019 | VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product ... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 684... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 680278... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 19, 2019 | Automated Impella Controller (AIC) with the below product descriptions and co... | Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in... | Class II | Abiomed, Inc. |
| Feb 14, 2019 | SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomograp... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2019 | SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed to... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2019 | SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomogra... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2019 | SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spira... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 8, 2019 | Omega Systems These devices are intended to be used in the environment whe... | The firm is recalling their Delta family of patient monitors software due to cybersecurity vulner... | Class II | Draegar Medical Systems, Inc. |
| Feb 8, 2019 | Infinity Delta Family patient monitors The Infinity Delta Series (Delta/De... | The firm is recalling their Delta family of patient monitors software due to cybersecurity vulner... | Class II | Draegar Medical Systems, Inc. |
| Feb 4, 2019 | Cobas¿ infinity central lab IT solution Material Number: 07154003001 Ca... | Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential ... | Class II | Roche Diagnostics Corporation |
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.