Z-1274-2018Class II

SporAmpule Biological Indicator Catalog Number SPS5-100

Name: Z-1274-2018 SporAmpule Biological Indicator Catalog Number SPS5-100
Creator: Mesa Laboratories Bozeman Manufacturing Facility
Published: 2018-02-12
License: https://open.fda.gov/license/

Mesa Laboratories Inc / initiated 2018-02-12 / Terminated

FDA source

Mesa Laboratories Bozeman Manufacturing Facility began a recall of SporAmpule Biological Indicator Catalog Number SPS5-100 on 2018-02-12. FDA classified it as Class II and gives the reason as "The concentration of bromocresol purple in the recalled lots does not conform to specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1274-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-12
Posted: 2018-03-29
Terminated: 2018-07-03
Recalling firm: Mesa Laboratories Inc
Product: SporAmpule Biological Indicator Catalog Number SPS5-100
Product code: FRC Indicator, Biological Sterilization Process
Reason for recall: The concentration of bromocresol purple in the recalled lots does not conform to specification.
FDA root cause: Other
Action: Per the Recall Strategy, consignees have been requested to immediately discontinue use and discard according to site procedures.
Quantity in commerce: 40,000 units
Distribution: United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan
Product codes and lots: Lots: SPS-696, SPS-697, SPS-698

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1274-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1273-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-29
Z-1274-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-29

Product code FRC

K971432Class IIProsporeRaven Biological Laboratories, Inc. / cleared 1997-05-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)