June 4, 2025Medical DevicesFDA
NxStage Medical Inc recalls NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RF
Hazard: Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.
June 4, 2025Medical DevicesFDA
Straumann USA LLC recalls GM Helix Acqua Implant, Article Number: 140.985
Hazard: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
June 4, 2025Medical DevicesFDA
Straumann USA LLC recalls GM Helix Acqua Implant, Article Number: 140.984
Hazard: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
June 4, 2025Medical DevicesFDA
Straumann USA LLC recalls Plus Initial Drill, Article Number: 103.170;
Hazard: The referred batch was produced without the laser engraving of 7 mm.
June 4, 2025Medical DevicesFDA
Pro-Med Instruments Gmbh recalls DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Hazard: Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
June 4, 2025Medical DevicesFDA
Ultra Clean Systems, Inc. recalls Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning
Hazard: During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
June 4, 2025Medical DevicesFDA
C-RAD POSITIONING AB recalls Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (
Hazard: Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Hazard: Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
June 4, 2025Medical DevicesFDA
Prismatik Dentalcraft, Inc. recalls Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219
Hazard: Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
June 4, 2025Medical DevicesFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL 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 SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
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 DIAGNOSTICS ALINITY I ANTI-CCPS 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 DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) 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 DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) 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 DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
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 DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
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 DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
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 DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS 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 POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
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 DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
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 DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA 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 DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B 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 DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) 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 DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
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 DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
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 HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE 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
Mckesson Medical-Surgical Inc. Corporate Office recalls HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE 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
Mckesson Medical-Surgical Inc. Corporate Office recalls ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (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 ANTI-B BIOCLONE 10ML3X10ML.
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 TOTAL BILI-ALKP XT (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.