Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST" — Class II medical device recall Z-1313-2024
Ongoing recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2024-03-27, distributed nationwide. Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, ca
| Recall number | Z-1313-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States |
| Recall initiated | 2024-01-09 |
| Classified | 2024-03-19 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 25 units |
| Reason classes | temperature control |
| UPC / GTIN / UDI-DI | 10724995220072 |
| Model numbers | LCC101 |
Product
Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
Reason for recall
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
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-1313-2024. 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.