FDA Medical Device Recalls (openFDA)
Innovative Sterlization Technologies LLC: OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
- Recall number
- Z-0153-2016
- Recalling firm
- Innovative Sterlization Technologies LLC
- Product
- OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
- Status
- Terminated
- Initiated
- 2014-02-03
- Posted
- 2015-10-22
- Terminated
- 2016-02-04
- Reason
- The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F.
- Root cause
- Process control
- Action
- The firm sent an Urgent Medical Device Recall letter dated September 14, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to fill out the attached response SASE mailer and return to or fax to the address/number identified below: Innovative Sterilization Technologies, LLC, 7625 Paragon Road, Suite A Dayton, OH 45459, 937-286-3571 (C), 937-630-4346 (F), 937-619-0138 x 202 (Office), dbillman@ISTSterilization.com
- Quantity
- M2104 - 25 units; M2408 - 84 units
- Distribution
- US Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV.
- Lot, serial or model codes
- M2104 Lot # 044305, 044379, 044380 & 044418. M2408 Lot # 044296, 022304, 044381, 044420, 044421 & 044422.
- 510(k) numbers
- ["K052567"]
- PMA numbers
- not on file
- Product code
- KCT
- Firm FEI
- 3010772758
- Firm city
- Dayton
- Firm state
- OH
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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