VERIFY Steam Test Pack — Class II medical device recall Z-0780-2023
Ongoing recall by Steris Corporation, reported 2023-01-11, distributed nationwide. Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inc
| Recall number | Z-0780-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2022-12-12 |
| Classified | 2023-01-03 |
| Reported by FDA | 2023-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 60 boxes |
| Reason classes | chemical contamination |
| UPC / GTIN / UDI-DI | 10724995023840 |
| Lot numbers | 230613 |
| Model numbers | S3065 |
Product
VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Reason for recall
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
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-0780-2023. 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.