FDA recall record · openFDA
Mckesson Medical-Surgical Inc. Corporate Office
50 FDA recalls on record (2024–2025) — 10 drug,40 device. 45 still ongoing.
0
Class I (most serious)
50
Class II
0
Class III
45
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored out 32
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temp 5
cGMP Deviations: Products were stored outside the drug label specifications. 3
CGMP Deviations; potential temperature excursions due to transit delays 3
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered 2
Recalls
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Class II 2025-04-21 Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, M Class II 2025-04-25 BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK. Class II 2025-04-21 PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, Class II 2025-04-21 Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Class II 2025-04-25 SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET. Class II 2025-04-24 ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE. Class II 2025-04-24 ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML. Class II 2025-04-24 ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT. Class II 2025-04-24 ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT. Class II 2025-04-24 ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT. Class II 2025-04-24 ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR. Class II 2025-04-24 ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT. Class II 2025-04-24 Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020 Class II 2025-07-30 ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES. Class II 2025-04-24 HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT. Class II 2025-04-24 ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT. Class II 2025-04-24 ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR. Class II 2025-04-24 BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA. Class II 2025-04-24 ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT. Class II 2025-04-24 HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL. Class II 2025-04-24 ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT. Class II 2025-04-24 HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE. Class II 2025-04-24 ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR. Class II 2025-04-24 HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL. Class II 2025-04-24 ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT. Class II 2025-04-24 ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT. Class II 2025-04-24 ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION. Class II 2025-04-24 ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR. Class II 2025-04-24 ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST. Class II 2025-04-24 ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR. Class II 2025-04-24 ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT. Class II 2025-04-24 ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT. Class II 2025-04-24 ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3. Class II 2025-04-24 ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL Class II 2025-04-24 ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT. Class II 2025-04-24 BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA. Class II 2025-04-24 ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT. Class II 2025-04-24 Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceut Class II 2024-02-07 Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma L Class II 2024-02-07 Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649- Class II 2024-02-07 Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and Class II 2024-09-11 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208 Class II 2024-09-11 Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST" Class II 2024-01-09 Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis Class II 2024-01-09 Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Numb Class II 2024-04-23 Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL Class II 2024-01-09 Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Class II 2024-01-09 Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a co Class II 2024-09-17 Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL Class II 2024-01-09
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.