SporAmpule Biological Indicator Catalog Number SPS5-100 — Class II medical device recall Z-1274-2018
Terminated recall by Mesa Laboratories Bozeman Manufacturing Facility, reported 2018-04-04. The concentration of bromocresol purple in the recalled lots does not conform to specification.
| Recall number | Z-1274-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mesa Laboratories Bozeman Manufacturing Facility, Boseman, MT, United States |
| Recall initiated | 2018-02-12 |
| Classified | 2018-03-29 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2018-07-03 |
| Countries outside the US | CA, CN, FR, HK, IL, JO, JP, KR, PL, SG |
| Quantity | 40,000 units |
| Lot numbers | SPS-696, SPS-697, SPS-698 |
| Model numbers | SPS5-100 |
Product
SporAmpule Biological Indicator Catalog Number SPS5-100
Reason for recall
The concentration of bromocresol purple in the recalled lots does not conform to specification.
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-1274-2018. 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.