Mckesson Medical-Surgical Inc. Corporate Office FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • No warning letters matched by name
Inspections 0 0 OAI
Recalls 276 0 Class I (0%)
Warning letters 0 None on file
510(k) clearances 0 None on file

Mckesson Medical-Surgical Inc. Corporate Office has 276 FDA recalls, 0 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Mckesson Medical-Surgical Inc. Corporate Office" is on file.

What these totals cover: FDA records filed under the name "Mckesson Medical-Surgical Inc. Corporate Office".

Latest recall
Z-2337-2025 · Class II · Jul 30, 2025

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls276Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections0Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Mckesson Medical-Surgical Inc. Corporate Office's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Mckesson Medical-Surgical Inc. Corporate Office: FDA recall records per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
2025000380
2024000120
202300000
20220002250
202100010
202000000
201900000
201800000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent recalls

276 recall records from Jun 2, 2021 to Jul 30, 2025. Showing the 20 most recent. View all 276 recall records

NumberClassProductDate
Z-2337-2025Class IIClearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020Jul 30, 2025
D-0401-2025Class IIInfuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL)…Apr 25, 2025
D-0400-2025Class IIMedroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only…Apr 25, 2025
Z-1839-2025Class IIHEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.Apr 24, 2025
Z-1842-2025Class IIABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.Apr 24, 2025
Z-1838-2025Class IIHEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.Apr 24, 2025
Z-1836-2025Class IIORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.Apr 24, 2025
Z-1843-2025Class IIABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.Apr 24, 2025
Z-1837-2025Class IIORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.Apr 24, 2025
Z-1827-2025Class IIHEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.Apr 24, 2025
Z-1835-2025Class IIORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.Apr 24, 2025
Z-1825-2025Class IIABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.Apr 24, 2025
Z-1847-2025Class IIABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.Apr 24, 2025
Z-1844-2025Class IIABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.Apr 24, 2025
Z-1849-2025Class IIABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.Apr 24, 2025
Z-1845-2025Class IIABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.Apr 24, 2025
Z-1846-2025Class IIABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.Apr 24, 2025
Z-1850-2025Class IIABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.Apr 24, 2025
Z-1833-2025Class IIORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.Apr 24, 2025
Z-1828-2025Class IIBD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.Apr 24, 2025

Mckesson Medical-Surgical Inc. Corporate Office and the FDA: common questions

Has Mckesson Medical-Surgical Inc. Corporate Office received an FDA warning letter?

No FDA warning letter addressed to the name "Mckesson Medical-Surgical Inc. Corporate Office" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Mckesson Medical-Surgical Inc. Corporate Office received an FDA Form 483?

FDA has not published a Form 483 for "Mckesson Medical-Surgical Inc. Corporate Office" in its reading room. FDA publishes some Form 483s, not all of them.

Has Mckesson Medical-Surgical Inc. Corporate Office had an FDA recall?

Yes. Mckesson Medical-Surgical Inc. Corporate Office has 276 FDA recalls on record. The most recent started Jul 30, 2025.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.