FDA Device recall Z-1274-2018
SporAmpule Biological Indicator Catalog Number SPS5-100
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of SporAmpule Biological Indicator Catalog Number SPS5-100 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-1274-2018 |
| 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
SporAmpule Biological Indicator Catalog Number SPS5-100
Reason
The concentration of bromocresol purple in the recalled lots does not conform to specification.
Identifiers
| code_info | Lots: SPS-696, SPS-697, SPS-698 |
|---|
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-1274-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.