Innovative Sterlization Technologies LLC: Medical Device Recall in 2015 - (Recall #: Z-0153-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices

Product Classification:

Class II

Date Initiated: February 3, 2014

Date Posted: October 28, 2015

Recall Number: Z-0153-2016

Event ID: 72011

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.

Status: Terminated

Product Quantity: M2104 - 25 units; M2408 - 84 units

Code Information:

M2104 Lot # 044305, 044379, 044380 & 044418. M2408 Lot # 044296, 022304, 044381, 044420, 044421 & 044422.

Distribution Pattern:

US Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV.

Voluntary or Mandated:

Voluntary: Firm initiated