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 |
|---|---|---|---|---|
| Dec 19, 2019 | RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041... | Software version UI2550642107 for the RX Daytona + instrument released to correct the following i... | Class II | Randox Laboratories, Limited |
| Dec 12, 2019 | ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 | Combination of software and a component failure may cause audible alarms not to operate properly,... | Class I | ResMed Ltd. |
| Dec 11, 2019 | Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.... | Incorrect reference ranges of analytes. | Class II | Abaxis Inc |
| Nov 19, 2019 | Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Ver... | It was reported that the user's low alarm feature on the iOS application were not properly alert... | Class II | Dexcom Inc |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy E... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Tril... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is inte... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is int... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is i... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is inten... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is i... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 18, 2019 | RayStation stand-alone software treatment planning system, Model Numbers 4.0,... | Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 18, 2019 | ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 ... | Registering dose and structures in the treatment delivery workflow could result in an alignment d... | Class II | Viewray, Inc. |
| Nov 14, 2019 | Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 1009... | In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collis... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 28, 2019 | Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM anti... | Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneo... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 22, 2019 | BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation | Following Customers complaints, investigations have been initiated on potentially false results o... | Class II | Biomerieux Inc |
| Oct 15, 2019 | CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0 | There is a potential that an image from a previous patient study to show up in a later patient s... | Class II | Cuattro LLC |
| Oct 11, 2019 | Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions... | On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Mult... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 9, 2019 | Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower... | The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of... | Class II | Draegar Medical Systems, Inc. |
| Oct 7, 2019 | Software versions syngo CT VB20 running on the following Siemens SOMATOM CT ... | Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanne... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 4, 2019 | Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance Sy... | The Fiducial Array may mismatch their measurement files resulting in failed landmark check. | Class II | Neocis Inc. |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 3, 2019 | Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer | There is a potential for Medtronic programmer and remote monitoring software applications to disp... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 3, 2019 | Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Man... | There is a potential for Medtronic programmer and remote monitoring software applications to disp... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 3, 2019 | Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer | There is a potential for Medtronic programmer and remote monitoring software applications to disp... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 1, 2019 | Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679... | NIBP valve assembly board subject to this recall includes enhancements that are not included in t... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Oct 1, 2019 | Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00,... | NIBP valve assembly board subject to this recall includes enhancements that are not included in t... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Oct 1, 2019 | Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00... | NIBP valve assembly board subject to this recall includes enhancements that are not included in t... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Oct 1, 2019 | Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679... | NIBP valve assembly board subject to this recall includes enhancements that are not included in t... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Sep 26, 2019 | Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer ... | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectl... | Class II | Life Technologies Holdings Pte Ltd |
| Sep 26, 2019 | Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Cust... | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectl... | Class II | Life Technologies Holdings Pte Ltd |
| Sep 26, 2019 | Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Cust... | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectl... | Class II | Life Technologies Holdings Pte Ltd |
| Sep 26, 2019 | Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM ... | Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectl... | Class II | Life Technologies Holdings Pte Ltd |
| Sep 25, 2019 | Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MAN... | The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Crani... | Class II | Brainlab AG |
| Sep 24, 2019 | MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology in... | The user may inadvertently enter Metric values into Height and Weight fields labeled with US Stan... | Class II | Elekta Impac Software |
| Sep 24, 2019 | SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system | SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 23, 2019 | TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and ... | The firm discovered a software issue associated with the Image-Com module/clinical application pa... | Class II | Tomtec Imaging Systems Gmbh |
| Sep 22, 2019 | Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indica... | The navigated values displayed when using the LPI instrumentation are incorrect due to software i... | Class II | Blue Ortho |
| Sep 18, 2019 | Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T7... | GN Hearing received reports from our manufacturing site in US regarding a software bug in our ser... | Class II | GN Hearing A/S |
| Sep 18, 2019 | In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP... | GN Hearing received reports from our manufacturing site in US regarding a software bug in our ser... | Class II | GN Hearing A/S |
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.