EZTest Steam Biological Indicator — Class II medical device recall Z-1824-2013
Terminated recall by Steritec Products Mfc. Co., Inc., reported 2013-08-07, distributed nationwide. Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest
| Recall number | Z-1824-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steritec Products Mfc. Co., Inc., Englewood, CO, United States |
| Recall initiated | 2013-06-10 |
| Classified | 2013-07-29 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2013-12-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CZ, IT, TR |
| Quantity | 14,900 units |
| Reason classes | labeling |
| Lot numbers | S-444 |
Product
EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
Reason for recall
Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
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-1824-2013. 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.