Data Foundry

Medical device recalls 2022

a — Class III medical device recall Z-1790-2022

Ongoing recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2022-10-05, distributed nationwide. Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperature

Recall numberZ-1790-2022
Product typeMedical device
ClassificationClass III
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States
Recall initiated2022-05-25
Classified2022-09-26
Reported by FDA2022-10-05
DistributedNationwide (US)
Reason classestemperature control
UPC / GTIN / UDI-DI00732224720074, 00732224720081, 10732224720071, 10732224720088, 50732224720079, 50732224720086
Model numbersCS-020, CS-100

Product

a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b. SPORVIEW CULTURE SET SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-100

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1790-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.