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Mckesson Medical-Surgical Inc. Corpora
Mckesson Medical-Surgical Inc. Corporate Office: 119 FDA recall reports
Every medical device recall the FDA has published for Mckesson Medical-Surgical Inc. Corporate Office. The fault, and how the agency graded it.
119Reports
0Class I
117Ongoing
2025-08-27Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Z-2337-2025 · Class II · reported 2025-08-27 · Ongoing
- Why it was recalled
- 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.
- Product
- Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
- Where it went
- US Nationwide distribution in the state of Georgia.
- How much
- 5 kits
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
Z-1854-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 1 unit
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
Z-1846-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 25 units
ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
Z-1836-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 1 unit
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
Z-1837-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 60 units
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
Z-1842-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 4 units
ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
Z-1851-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 1 unit
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
Z-1850-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 1 unit
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
Z-1843-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 1 unit
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
Z-1825-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 100 units
HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
Z-1855-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 1 unit
ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
Z-1831-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 5 units
ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
Z-1840-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 1 unit
BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
Z-1828-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 100 units
ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
Z-1847-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 400 units
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
Z-1838-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 1 unit
ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
Z-1844-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 2 units
HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
Z-1827-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 4 units
ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
Z-1848-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 1 unit
HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
Z-1839-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 1 unit
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
Z-1832-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 10 units
ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.
Z-1852-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 2 units
ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
Z-1841-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 1 unit
ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
Z-1849-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 1 unit
ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
Z-1826-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 50 units
ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
Z-1845-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 1 unit
ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
Z-1833-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 300 units
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
Z-1830-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 8 units
ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
Z-1834-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 3 units
ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
Z-1824-2025 · Class II · reported 2025-06-04 · Ongoing
- Why it was recalled
- 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.
- Product
- ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
- Where it went
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- How much
- 1 unit
Showing the 30 most recent of 119. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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