Recall Z-2337-2025— Mckesson Medical-Surgical Inc. Corporate Office

Name: FDA recall Z-2337-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-30

Class II · Ongoing

Class II FDA medical device recall by Mckesson Medical-Surgical Inc. Corporate Office, initiated 2025-07-30. It names one FDA 510(k) clearance: K010582. Product: Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020. Reason: 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..

Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Classification: Class II
Status: Ongoing
Initiated: 2025-07-30
Firm location: Richmond, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K010582 — ACON STREP A RAPID TEST STRIPAcon Laboratories Co.·cleared 2001-05-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.