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.

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DateProductReasonClassFirm
Feb 3, 2020 ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4M... The firm received reports of occurrences where the barcode reader misinterpreted the contents of... Class II Radiometer Medical ApS
Jan 28, 2020 QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed... When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file r... Class II Qiagen Sciences LLC
Jan 24, 2020 LN 3R70-01; software version 2.6.2 and earlier. The software is used with th... Abbott has identified potential performance issues for the Alinity ci -series Software version 2.... Class II Abbott Gmbh & Co. KG
Jan 23, 2020 DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an ... A software issue was identified which could result in user or patient injury, or may adversely im... Class II Ra Medical Systems, Inc.
Jan 22, 2020 Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. S... An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This ... Class II Braemar Manufacturing, LLC
Jan 22, 2020 Triton Canister System (finished part numbers FG 12009, for 3L canisters, and... Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance.... Class II Stryker Instruments Div. of Stryker Corporation
Jan 22, 2020 Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. S... An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This ... Class II Braemar Manufacturing, LLC
Jan 22, 2020 Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36... Past updates to programmers and transmitters may lead some implantable cardioverter defibrillator... Class II St Jude Medical, Cardiac Rhythm Management Divi...
Jan 17, 2020 LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPr... A security-only update was released via remote diagnostics on January 14, 2020 to customers with ... Class II Beckman Coulter Inc.
Jan 13, 2020 Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. Th... if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorde... Class II Philips North America, LLC
Jan 10, 2020 AIA-360 Automated Immunoassay Analyzer, Product Code 019945 A display screen software issue on the analyzer causes the display to freeze when display screen ... Class II Tosoh Bioscience Inc
Jan 8, 2020 SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a d... Two software issues (1) Using the override function in case of blocked system movements affecting... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a dev... A software bug may lead to one image to be assigned to two different patients, which could potent... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a... A software bug may lead to one image to be assigned to two different patients, which could potent... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is ... Two software issues (1) Using the override function in case of blocked system movements affecting... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic ... A software bug may lead to one image to be assigned to two different patients, which could potent... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Mod... Two software issues (1) Using the override function in case of blocked system movements affecting... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is ... Two software issues (1) Using the override function in case of blocked system movements affecting... Class II Siemens Medical Solutions USA, Inc
Jan 6, 2020 ROSA One 3.1 Brain Application Some cross-sectional images from the image acquisitions of the patients head may not be reconstru... Class II MEDTECH SAS
Jan 6, 2020 Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software... A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. Class II Siemens Healthcare Diagnostics, Inc.
Jan 6, 2020 Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software... A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. Class II Siemens Healthcare Diagnostics, Inc.
Jan 6, 2020 ROSA Brain 3.0 Application-Brain Some cross-sectional images from the image acquisitions of the patients head may not be reconstru... Class II MEDTECH SAS
Dec 31, 2019 Koios DS Breast <series 1.0>. The device is a software application which assi... Affected software product versions were found during internal audit to have been marketed for sal... Class II Koios Medical, Inc.
Dec 23, 2019 VesselNavigator application used with Philips Azurion (Azurion 7 Series) Soft... Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselN... Class II Philips North America, LLC
Dec 19, 2019 CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xr... When using the Table Up/Down button, the system may experience Error 80, which locks the geometry... Class II Philips Medical Systems Gmbh, DMC
Dec 19, 2019 RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4... Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module ma... Class II RAYSEARCH LABORATORIES AB
Dec 19, 2019 CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xr... When using the Table Up/Down button, the system may experience Error 80, which locks the geometry... Class II Philips Medical Systems Gmbh, DMC
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

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.