FDA Medical Device Recalls (openFDA)
Mesa Laboratories Bozeman Manufacturing Facility: SporAmpule Biological Indicator Catalog Number SPS5-100
- Recall number
- Z-1274-2018
- Recalling firm
- Mesa Laboratories Bozeman Manufacturing Facility
- Product
- SporAmpule Biological Indicator Catalog Number SPS5-100
- Status
- Terminated
- Initiated
- 2018-02-12
- Posted
- not on file
- Terminated
- 2018-07-03
- Reason
- The concentration of bromocresol purple in the recalled lots does not conform to specification.
- Root cause
- Other
- Action
- Per the Recall Strategy, consignees have been requested to immediately discontinue use and discard according to site procedures.
- Quantity
- 40,000 units
- Distribution
- United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan
- Lot, serial or model codes
- Lots: SPS-696, SPS-697, SPS-698
- 510(k) numbers
- ["K971432"]
- PMA numbers
- not on file
- Product code
- FRC
- Firm FEI
- 3013667284
- Firm city
- Boseman
- Firm state
- MT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28