Data Foundry

Medical device recalls 2022

Verify SixCess Challenge Pack — Class III medical device recall Z-1736-2022

Terminated recall by Steris Corporation Hopkins Facility, reported 2022-09-21, distributed in AK, AR, AZ, CA, CO, FL, GA, IA…. Product contains incorrect chemical indicators in packaging.

Recall numberZ-1736-2022
Product typeMedical device
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSteris Corporation Hopkins Facility, Mentor, OH, United States
Recall initiated2022-08-10
Classified2022-09-09
Reported by FDA2022-09-21
Terminated2024-10-30
DistributedAK, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MN, MO, MS, NE, NH, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WY
Quantity619 boxes
Reason classeschemical contamination
UPC / GTIN / UDI-DI10724995088955
Lot numbers3411228A
Model numbersLCC003

Product

Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.

Reason for recall

Product contains incorrect chemical indicators in packaging.

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-1736-2022. 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.