Data Foundry

Medical device recalls 2022

SPS MEDICAL SUPPLY Crosstex International Sterilization Roll… — Class III medical device recall Z-1791-2022

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-1791-2022
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)
Quantity1 cases
Reason classestemperature control
UPC / GTIN / UDI-DI00732224109824, 10732224109821, 50732224109829
Model numbersSCT3

Product

SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X 100 Foot Transparent / Blue Self Seal Paper / Film Model Number: SCT3.

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-1791-2022. 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.