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 |
|---|---|---|---|---|
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, M... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 1... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V R... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT R... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK,... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, M... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 29, 2018 | IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software p... | Quality control results are not processed for Abbott Diagnostics Alinity ci series (abdicqii) ins... | Class II | Data Innovations, LLC |
| Aug 28, 2018 | VidiStar(TM) PACS & DICOM Viewer Software system | The secure filesystem client software used in the interface between the Vidistar PACS and an EHR ... | Class II | Hitachi Healthcare Americas Corp Informatics Di... |
| 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 |
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.