Mckesson Medical-Surgical Inc. Corporate Office Recalls
50 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (40)
- Class II
July 30, 2025
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.
- Class II
April 24, 2025
ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.
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.
- Class II
April 24, 2025
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
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.
- Class II
April 24, 2025
ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
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.
- Class II
April 24, 2025
ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
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.
- Class II
April 24, 2025
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
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.
- Class II
April 24, 2025
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
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.
- Class II
April 24, 2025
ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
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.
- Class II
April 24, 2025
HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
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.
- Class II
April 24, 2025
ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
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.
- Class II
April 24, 2025
ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.
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.
- Class II
April 24, 2025
BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.
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.
- Class II
April 24, 2025
ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.
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.
- Class II
April 24, 2025
ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
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.
- Class II
April 24, 2025
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
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.
- Class II
April 24, 2025
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
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.
- Class II
April 24, 2025
ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
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.
- Class II
April 24, 2025
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
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.
- Class II
April 24, 2025
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
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.
- Class II
April 24, 2025
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
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.
- Class II
April 24, 2025
HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
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.
- Class II
April 24, 2025
ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
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.
- Class II
April 24, 2025
ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
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.
- Class II
April 24, 2025
ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
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.
- Class II
April 24, 2025
ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
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.
- Class II
April 24, 2025
ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
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.
- Class II
April 24, 2025
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
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.
- Class II
April 24, 2025
ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
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.
- Class II
April 24, 2025
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
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.
- Class II
April 24, 2025
BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
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.
- Class II
April 24, 2025
ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
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.
- Class II
April 24, 2025
HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
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.
- Class II
April 24, 2025
ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
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.
- Class II
September 17, 2024
Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test
The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25¿C. This may lead to delay in patients' results.
- Class II
April 23, 2024
Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal Catalog Number: 8881560125
Quarantined product was inadvertently distributed
- Class II
January 9, 2024
Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
- Class II
January 9, 2024
Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes .
- Class II
January 9, 2024
Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
- Class II
January 9, 2024
Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
- Class II
January 9, 2024
Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
Drug Recalls (10)
- Class II
April 25, 2025
Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthc
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
- Class II
April 25, 2025
Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
- Class II
April 21, 2025
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.
CGMP Deviations; potential temperature excursions due to transit delays
- Class II
April 21, 2025
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
CGMP Deviations; potential temperature excursions due to transit delays
- Class II
April 21, 2025
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
CGMP Deviations; potential temperature excursions due to transit delays
- Class II
September 11, 2024
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Di
cGMP Deviations: Temperature excursion
- Class II
September 11, 2024
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
Temperature abuse: Products exposed to improper temperature above drug label specifications.
- Class II
February 7, 2024
Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10
cGMP Deviations: Products were stored outside the drug label specifications.
- Class II
February 7, 2024
Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
cGMP Deviations: Products were stored outside the drug label specifications.
- Class II
February 7, 2024
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10
cGMP Deviations: Products were stored outside the drug label specifications.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.