FDA Medical Device Recalls (openFDA)
Mesa Laboratories, Inc., Bozeman Manufacturing Facility: Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
- Recall number
- Z-1868-2013
- Recalling firm
- Mesa Laboratories, Inc., Bozeman Manufacturing Facility
- Product
- Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
- Status
- Terminated
- Initiated
- 2013-06-04
- Posted
- 2013-08-01
- Terminated
- 2013-11-22
- Reason
- Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
- Root cause
- Nonconforming Material/Component
- Action
- Mesa Labs sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions contact Mesa Labs at BI-Support@mesalabs.com.
- Quantity
- 2447/100 count boxes
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Egypt, Greece, India,Israel, Japan, Jordan, Malaysia, Mexico, Milanese, Netherlands, Peru, Portugal, Pozan, Romania, Spain, Sweden, Taiwan, Thailand, United Kingdom, and Uruguay.
- Lot, serial or model codes
- Lot No SR-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21; Lot No SR-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15. Lot No SR-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18.
- 510(k) numbers
- ["K093794"]
- PMA numbers
- not on file
- Product code
- FRC
- Firm FEI
- 3013667284
- Firm city
- Bozeman
- 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