Mesa Laboratories Bozeman Manufacturing Facility: Medical Device Recall in 2018 - (Recall #: Z-1274-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

SporAmpule Biological Indicator Catalog Number SPS5-100

Product Classification:

Class II

Date Initiated: February 12, 2018

Date Posted: April 4, 2018

Recall Number: Z-1274-2018

Event ID: 79374

Reason for Recall:

The concentration of bromocresol purple in the recalled lots does not conform to specification.

Status: Terminated

Product Quantity: 40,000 units

Code Information:

Lots: SPS-696, SPS-697, SPS-698

Distribution Pattern:

United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan

Voluntary or Mandated:

Voluntary: Firm initiated