Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM — Class II medical device recall Z-1868-2013
Terminated recall by Mesa Laboratories, Inc., Bozeman Manufacturing Facility, reported 2013-08-07, distributed nationwide. Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out tim
| Recall number | Z-1868-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mesa Laboratories, Inc., Bozeman Manufacturing Facility, Bozeman, MT, United States |
| Recall initiated | 2013-06-04 |
| Classified | 2013-08-01 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2013-11-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BG, BR, CA, CN, CO, EG, ES, GB, GR, HR, IL, IN, JO, JP, MX, MY, NL, PE, PT, RO, SE, TH, TW, UY |
| Quantity | 2,447 |
| Reason classes | labeling |
| Lot numbers | SR-444, SR-445, SR-447 |
Product
Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Reason for recall
Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out 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-1868-2013. 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.