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
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.