FDA Medical Device Recalls (openFDA)
Steritec Products Mfc. Co., Inc.: EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
- Recall number
- Z-1824-2013
- Recalling firm
- Steritec Products Mfc. Co., Inc.
- Product
- EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
- Status
- Terminated
- Initiated
- 2013-06-10
- Posted
- 2013-07-29
- Terminated
- 2013-12-19
- Reason
- Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
- Root cause
- Nonconforming Material/Component
- Action
- The firm, SteriTec, sent all customers recall notifications via e-mail. The e-mail included a .pdf file of the recall notification letter entitled "URGENT: MEDICAL DEVICE RECALL" dated June 11, 2013. The letter described the product, problem and actions to be taken. The letter also informed customers of MesaLabs, "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2013 to its customers. The customers were instructed to notify SteriTec products of receipt of this notification via email at: Jon@SteriTecproducts.com or fax to: 303-660-4213 Attn: Director Regulatory Affairs; examine the lot number printed on the packaging components; place affected items in hold and do not sell or distribute these lots; record inventory of all items remaining in your warehouse and all items that have been distributed; advise SteriTec of the status of all inventory you received used or unused, if you have distributed the affected product to other locations within your healthcare system, notify them immediately of this recall, ask them to provide inventory status and proceed with destruction or return via instructions provided in letter-If you have shipping questions, please contact SteriTec directly at 303-660-4201, or email us at: Info@SteriTecproducts.com, and also provide this notice to anyone in your facility that needs to be informed. Should you have any questions or concerns, please do not hesitate to contact Director of Regulatory Affairs and Quality Assurance or our offices at 303-660-4201. SteriTec's hours of operation are 7:30am Mountain Standard Time (MST) through 5:00pm MST.
- Quantity
- 14,900 units
- Distribution
- Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
- Lot, serial or model codes
- Affected Biological Indicator Lot No.: S-444
- 510(k) numbers
- ["K930682"]
- PMA numbers
- not on file
- Product code
- FRC
- Firm FEI
- 1000125215
- Firm city
- Englewood
- Firm state
- CO
- 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