FDA Device recall Z-0153-2016
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
- FDA Device
- Class II
- terminated
- Published 2015-10-28
On 2015-10-28 the FDA classified a Class II recall of OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices by Innovative Sterlization Technologies, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0153-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-03 |
| Published | 2015-10-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Innovative Sterlization Technologies |
| Distribution | US |
Product
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
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.
Identifiers
| code_info | M2104 Lot # 044305, 044379, 044380 & 044418. M2408 Lot # 044296, 022304, 044381, 044420, 044421 & 044422. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0153-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.