Browse Device Recalls

3,099 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,099 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 3,099 FDA device recalls.

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DateProductReasonClassFirm
Aug 15, 2018 MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple ... When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound T... Class II Agilent Technologies, Inc.
Aug 13, 2018 VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Entero... Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were ma... Class II bioMerieux, Inc.
Aug 13, 2018 VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Entero... Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were ma... Class II bioMerieux, Inc.
Aug 3, 2018 Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Versio... Released with an incorrect, older firmware version installed. May result in intermittent loss of... Class II Invivo Corporation
Aug 1, 2018 Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model ... A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a ... Class II ICU Medical Inc
Aug 1, 2018 AIRO Mobile CT System Model # MobiCT-32 The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with softwar... Class II Mobius Imaging, LLC
Jul 26, 2018 Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: H... When creating a correction plan with the Correct Axial First button selected and the No. of cor... Class II Stryker GmbH
Jul 23, 2018 Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On ... There is a software issue that can potentially impact sample identification and traceability unde... Class II Tecan US, Inc.
Jul 13, 2018 G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use... Analyzers were distributed with software which lacks a 510K Class II Tosoh Bioscience Inc
Jul 11, 2018 Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Un... Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while... Class I Spacelabs Healthcare, Ltd.
Jul 3, 2018 ABL800 analyzer, model numbers 393-800 and 393-801. The analyzer software may cause a mis-match of patient demographics and test results when a certa... Class II Radiometer America Inc
Jul 2, 2018 iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic ... The device and its accessories may not have been manufactured according to current Good Manufactu... Class II Hudson Scientific LLC
Jun 29, 2018 Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a mult... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vi... An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could... Class II Luminex Corporation
Jun 29, 2018 Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 RayStation stand-alone software treatment planning system, RayStation 4.5, R... If the beam model has a highly asymmetric primary source, it is not correctly taken into account ... Class II RAYSEARCH LABORATORIES AB
Jun 29, 2018 Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a ... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indic... The firm received a complaint where, during patient positioning, the technologist was adjusting t... Class II Hitachi Medical Systems America Inc
Jun 29, 2018 Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution ... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2018 Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a ... Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... Class II Siemens Healthcare Diagnostics, Inc.
Jun 28, 2018 The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARES... The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable. Class II Datex-Ohmeda, Inc.
Jun 25, 2018 POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA ... Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experien... Class II Bard Peripheral Vascular Inc
Jun 15, 2018 TRINIAS Digital Angiographic System intended to be used for cardiac angiograp... Due to a software issue the C-arm may unexpectedly moved when being moved to the park position an... Class II Shimadzu Medical Systems Usa Com
Jun 7, 2018 GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the foll... The latest on-site software version may not have been reinstalled at some sites after service act... Class II GE Medical Systems, LLC
Jun 7, 2018 GE Healthcare MRI Systems, Software Version 12.x, sold under the following pr... The latest on-site software version may not have been reinstalled at some sites after service act... Class II GE Medical Systems, LLC
Jun 7, 2018 GE Healthcare MRI Systems, Software Version 11.x, sold under the following pr... The latest on-site software version may not have been reinstalled at some sites after service act... Class II GE Medical Systems, LLC
Jun 6, 2018 RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, ... The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous... Class II RAYSEARCH LABORATORIES AB
Jun 6, 2018 G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 ... HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Cu... Class II Tosoh Bioscience Inc
Jun 1, 2018 Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1... Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visu... Class II Medtronic Navigation, Inc.
May 25, 2018 ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX A... The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take pla... Class II Radiometer America Inc
May 24, 2018 Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No.... Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... Class III Beckman Coulter Inc.
May 24, 2018 Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10... Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu... Class III Beckman Coulter Inc.
May 24, 2018 Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckma... Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... Class III Beckman Coulter Inc.
May 24, 2018 Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Dr... Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... Class III Beckman Coulter Inc.
May 24, 2018 Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Soft... Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... Class III Beckman Coulter Inc.
May 24, 2018 Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4... Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... Class III Beckman Coulter Inc.
May 24, 2018 Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured b... Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu... Class III Beckman Coulter Inc.
May 23, 2018 Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing... This email is to provide notification that, due to a software bug that has been corrected, the Ra... Class II Ortho Kinematics, Inc
May 10, 2018 Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS... Out of tolerance. Class II Mako Surgical Corporation
May 9, 2018 OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.... Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specificall... Class II Johnson & Johnson Surgical Vision Inc
May 8, 2018 ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Dev... Replacement of units lacking an updated device approval. Class II MEDTECH SAS
May 4, 2018 RX Imola (RX4900) For Professional Use for the quantitative in vitro deter... Abnormal premature termination of the software could affect the use of the analyser when running ... Class II Randox Laboratories
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 30, 2018 IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model... Five warning statements are missing from the instructions for use. Class II Philips Electronics North America Corporation
Apr 23, 2018 t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4... The fuel gauge, the component that reads and reports the battery parameters to the pump, could pr... Class II Tandem Diabetes Care Inc
Apr 20, 2018 SOMATOM go.Now, Material Number 11061618 There is a potential for a softw... There is a potential for a software issue that may cause the need for necessary patient rescans. Class II Siemens Medical Solutions USA, Inc
Apr 20, 2018 SOMATOM Go.Up, Material Number 11061628 There is a potential for a softwar... There is a potential for a software issue that may cause the need for necessary patient rescans. Class II Siemens Medical Solutions USA, 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.