June 4, 2025Medical DevicesFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
Hazard: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
June 4, 2025Medical DevicesFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
Hazard: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
June 4, 2025Medical DevicesFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
Hazard: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
June 4, 2025Medical DevicesFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
Hazard: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
June 4, 2025Medical DevicesFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
Hazard: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
June 4, 2025Medical DevicesFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.
Hazard: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
June 4, 2025Medical DevicesFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
Hazard: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
June 4, 2025Medical DevicesFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
Hazard: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
June 4, 2025Medical DevicesFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
Hazard: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
June 4, 2025Medical DevicesFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
Hazard: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
June 4, 2025Medical DevicesFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
Hazard: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
June 4, 2025Medical DevicesFDA
Maquet Cardiopulmonary Ag recalls Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital tran
Hazard: HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
June 4, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Hazard: Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
June 4, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Hazard: Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with
Hazard: Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with
Hazard: Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
June 4, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E10043
Hazard: There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
June 4, 2025Medical DevicesFDA
Beckman Coulter Ireland, Inc. recalls Apo B Reagent, REF: OSR6143
Hazard: The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
May 28, 2025Medical DevicesFDA
Advanced Bionics, LLC recalls HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Hazard: Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
May 28, 2025Medical DevicesFDA
Copan WASP recalls PhenoMATRIX
Hazard: AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.
May 28, 2025Medical DevicesFDA
Becton Dickinson Infusion Therapy Systems, Inc. recalls BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20
Hazard: Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.
May 28, 2025Medical DevicesFDA
Echopixel, Inc. recalls TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed fo
Hazard: Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.
May 28, 2025Medical DevicesFDA
Smith & Nephew, Inc. recalls META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Hazard: Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: Ingenia 3.0T CX; Model Number: 781271;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: Ingenia 1.5T CX; Model Number: 781262;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.