Medical devices, 2025: every recall, from FDA

Medical device recall Proxima Drape labeled as FACE LIFT Potential breach in pouch packaging which could lead to loss of sterility. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide

Medical device recall Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF,… Potential breach in pouch packaging which could lead to loss of sterility. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide

Medical device recall Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P Potential breach in pouch packaging which could lead to loss of sterility. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide

Medical device recall Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE Potential breach in pouch packaging which could lead to loss of sterility. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide

Medical device recall Helix Elite” Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed… The A549 human cell target (human cells for sample adequacy control) may give a late Ct value. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Texas named

Medical device recall Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different… Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Indiana, Kansas, Missouri, New Jersey, Nevada, Ohio, Texas, Virginia and Wisconsin named

Medical device recall Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different… Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Indiana, Kansas, Missouri, New Jersey, Nevada, Ohio, Texas, Virginia and Wisconsin named

Medical device recall Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different… Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Indiana, Kansas, Missouri, New Jersey, Nevada, Ohio, Texas, Virginia and Wisconsin named

Medical device recall BD Pyxis: Anesthesia Station ES Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data… Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named

Medical device recall Microstream Instructions for Use and Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience… Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Access 2 Immunoassay Analyzer Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase… Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide

Medical device recall DxI 9000 Access Immunoassay Analyzer Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0… Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, Texas and Washington named

Medical device recall DxI 9000 Access Immunoassay Analyzer the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety… Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide

Medical device recall Candida ID Antigen, REAG, AG Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and California and Oklahoma named

Medical device recall IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit Product is mislabeled with the incorrect fill volume. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, District of Columbia, Florida, Tennessee, Texas, Virginia and Wisconsin named

Medical device recall Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user… Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide

Medical device recall Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide

Medical device recall Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide

Medical device recall Zebra Thermal Barcode Printer GX430t Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement Report17 statesnamed in where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Florida, Georgia, Indiana, Kansas, Kentucky, Maryland, Michigan, Nebraska, New York, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin

Medical device recall Introcan Safety 3 Closed IV Catheter 22 Ga Increased risk for valve housing detachment causing leakage. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement Report16 statesnamed in where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereCalifornia, Florida, Georgia, Illinois, Indiana, Maryland, Minnesota, Missouri, North Carolina, New Mexico, New York, Pennsylvania, Tennessee, Texas, Virginia and Washington

Medical device recall VERICIS, Merge Cardio When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement… Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNo state named

Medical device recall Merge Cardio When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement… Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNo state named

Medical device recall Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within… Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide

Medical device recall CAPNOCHECK BCI Airway Adapter Airway adapter does not meet specification and may break off when attaching a valve or tube. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide

Medical device recall CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit. During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not… Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportMichiganthe one state its words name PublishedMar 26, 2025ClassClass IIStatusOngoingWhereMichigan

Medical device recall Synapse PACS Software Version 7.4.x The incorrect computed patient age is showing in VX for patients less than 3 months old. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement Report30 statesnamed in where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Tennessee, Texas, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall Portex Endotracheal Tube Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. FDA Class I, its most serious class Class IFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IStatusOngoingWhereNationwide

Medical device recall GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the… Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNo state named

Medical device recall GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the… Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNo state named

Medical device recall GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the… Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNo state named

Medical device recall GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the… Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNo state named

Medical device recall GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the… Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNo state named

Medical device recall GE Healthcare Revolution CT, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the… Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNo state named

Medical device recall GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the… Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNo state named

Medical device recall BD Alaris Systems Manager Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). FDA Class I, its most serious class Class IFDA’s classMar 19, 2025in FDA’s Enforcement Report21 statesnamed in where it went PublishedMar 19, 2025ClassClass IStatusOngoingWhereArizona, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin

Medical devices, 2025

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