FDA Device recall Z-1273-2018
ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471 by Mesa Laboratories Bozeman Manufacturing Facility, citing the concentration of bromocresol purple in the recalled lots does not conform to specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1273-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-12 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mesa Laboratories Bozeman Manufacturing Facility |
| Distribution | n/a |
Product
ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
Reason
The concentration of bromocresol purple in the recalled lots does not conform to specification.
Identifiers
| code_info | Lots: PS-673, PS-674, PS-675, PS-675 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1273-2018%22
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