FDA Medical Device Recalls (openFDA)
Mesa Laboratories Inc: ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.
- Recall number
- Z-1104-2017
- Recalling firm
- Mesa Laboratories Inc
- Product
- ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.
- Status
- Terminated
- Initiated
- 2016-04-04
- Posted
- not on file
- Terminated
- 2017-01-26
- Reason
- Product resistance has fallen outside of label claim within expiry.
- Root cause
- Process control
- Action
- MesaLabs sent an Urgent Notification letter dated April 4. 2016 to customers. Follow-up emails were sent to verify receipt. The letter identified the affected product, problem and actions to be taken. For questions contact MesaLabs technical support team via email at bi-support@mesalabs.com or call at 303-987-8000 ext. 10042.
- Quantity
- 328/ 50-count/ boxes; 16,400 individual units
- Distribution
- Product was distributed to: AL, AR, CA, FL, IA, MO, NE, NC, NY, OH, and WA. The product was also distributed internationally, including Mexico and Canada. There was no goverment or military distribution.
- Lot, serial or model codes
- Lot # 637, exp. date 12/2016
- 510(k) numbers
- ["K971432"]
- PMA numbers
- not on file
- Product code
- FRC
- Firm FEI
- 3013667284
- Firm city
- Omaha
- Firm state
- NE
- 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