OneTray Sealed Sterilization Containers Product Usage: A rigid… — Class II medical device recall Z-0153-2016
Terminated recall by Innovative Sterlization Technologies LLC, reported 2015-10-28, distributed nationwide. The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F
| Recall number | Z-0153-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Innovative Sterlization Technologies LLC, Dayton, OH, United States |
| Recall initiated | 2014-02-03 |
| Classified | 2015-10-21 |
| Reported by FDA | 2015-10-28 |
| Terminated | 2016-02-04 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | 022304, 044296, 044305, 044379, 044380, 044381, 044418, 044420, 044421, 044422, M2408 |
Product
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0153-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.