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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 |
| Jan 28, 2019 | ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens M... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 28, 2019 | ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Si... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 28, 2019 | ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens ... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 28, 2019 | ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Sie... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 17, 2019 | MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices | The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indica... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 10, 2019 | EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management S... | User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling ... | Class II | Bio-Rad Laboratories, Inc |
| Jan 9, 2019 | PageWriter TC50 Government Bundle, Product 860429, Software revisions up to a... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revis... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisio... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisi... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revis... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC30, Product 860306, Software revisions up to and including A.07.... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC20, Product 860332, Software revisions up to and including A.07.... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC50, Product 860310, Software revisions up to and including A.07.... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC70, Product 860315, Software revisions up to and including A.07.... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P... | For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, th... | Class II | NEUSOFT MEDICAL SYSTEMS IMP & EX |
| Jan 2, 2019 | BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 66... | A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 ... | Class III | Becton, Dickinson and Company, BD Biosciences |
| Dec 20, 2018 | AMSCO 3000 Series Washer/Disinfector Model # 3052 | The software in the systems may not process the cycle originally intended. This could result in d... | Class II | Steris Corporation |
| Dec 20, 2018 | AMSCO 5000 Series Washer/Disinfector Model # 5052 | The software in the systems may not process the cycle originally intended. This could result in d... | Class II | Steris Corporation |
| Dec 19, 2018 | Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagn... | A software update is being issued to correct multiple issues identified in the previous software ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 11, 2018 | AMIA Automated Peritoneal Dialysis System Product Usage: It is intended ... | Potential for the software on Automated PD System cyclers which can cause shortened dwell times d... | Class II | Baxter Healthcare Corporation |
| Dec 11, 2018 | Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended... | Potential for the software on Automated PD System cyclers which can cause shortened dwell times d... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2018 | VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE)... | VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may ex... | Class II | Carl Zeiss Meditec, Inc. |
| Dec 5, 2018 | The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to ... | When racks are front-loaded onto the sample presentation unit while samples from the automation l... | Class II | Beckman Coulter Inc. |
| Dec 5, 2018 | UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that ... | When racks are front-loaded onto the sample presentation unit while samples from the automation l... | Class II | Beckman Coulter Inc. |
| Dec 4, 2018 | Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 | Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order t... | Class III | Stryker Instruments Div. of Stryker Corporation |
| Dec 4, 2018 | DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is ... | After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which t... | Class II | Agfa-Gevaert, N.V. |
| Dec 3, 2018 | C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 ... | The Controller does not detect overpressure in the balloon during the application of non-dosing p... | Class II | PENTAX of America 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.