Mckesson Medical-Surgical Inc. Corporate Office: Medical Device Recall in 2022 - (Recall #: Z-1587-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.
Product Description:

a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c. McKesson Medical-Surgical McKesson TEST KIT, PREG HCG CASSETTE WAIVED Model Number: 5001

Product Classification:

Class II

Date Initiated: May 25, 2022
Date Posted: August 31, 2022
Recall Number: Z-1587-2022
Event ID: 90336
Reason for Recall:

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Status: Ongoing
Product Quantity: a. 108 b. 838 c. 1225
Code Information:

GTIN: 10612479218625; 20612479202768 all lots and expiration dates received during July 4th through September 30th, 2021. b. GTIN: 10612479218618; 20612479202751 All lots received between 7/4/21-9/30/21. c. GTIN: 10612479218601; 20612479202744

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated