ProSpore 4 mL Ampoule Biological indicator for steam sterilization — Class II medical device recall Z-1104-2017
Terminated recall by Mesa Laboratories Inc, reported 2017-02-01, distributed in AL, AR, CA, FL, IA, MO, NC, NE…. Product resistance has fallen outside of label claim within expiry.
| Recall number | Z-1104-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mesa Laboratories Inc, Omaha, NE, United States |
| Recall initiated | 2016-04-04 |
| Classified | 2017-01-26 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2017-01-26 |
| Distributed | AL, AR, CA, FL, IA, MO, NC, NE, NY, OH, WA |
| Countries outside the US | CA, MX |
| Reason classes | labeling |
| Lot numbers | 637 |
| Model numbers | PS-6-50 |
| Expiration dates | 2016-12 |
Product
ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.
Reason for recall
Product resistance has fallen outside of label claim within expiry.
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-1104-2017. 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.