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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Apr 16, 2018 | Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650... | The firm is advising physicians that exposure to sub-freezing temperatures during the supply chai... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Merlin PCS programmer (Model # 3650), Software (Model # 3330) | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 13, 2018 | Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Ca... | Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. | Class II | St Jude Medical, Cardiac Rhythm Management Divi... |
| Apr 3, 2018 | cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is ... | The syringe plunger on the device may be mounted in a tilted position, which applies mechanical s... | Class II | Roche Diagnostics Corporation |
| Mar 29, 2018 | iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iC... | The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufac... | Class II | Beckman Coulter Inc. |
| Mar 28, 2018 | RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 ... | The dose calculation accuracy may in some situations be less than expected. The user must be awar... | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2018 | Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS2040... | Software anomaly resulting in the loss of patient settings and stored patient data. | Class II | Draegar Medical Systems, Inc. |
| Mar 2, 2018 | BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 70... | Beckman Coulter has determined that there is a potential for under-reporting casts. This can occu... | Class II | Beckman Coulter Inc. |
| Mar 2, 2018 | BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-... | Beckman Coulter has determined that there is a potential for incorrect settings to be installed o... | Class II | Beckman Coulter Inc. |
| Feb 27, 2018 | AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system i... | There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may res... | Class II | Radiometer Medical ApS |
| Feb 22, 2018 | Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 333713869... | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | Class II | Roche Diagnostics Corporation |
| Feb 22, 2018 | cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 333715469... | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | Class II | Roche Diagnostics Corporation |
| Feb 22, 2018 | cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692... | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | Class II | Roche Diagnostics Corporation |
| Feb 22, 2018 | cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 331352269... | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | Class II | Roche Diagnostics Corporation |
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.