Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container Recalled by Innovative Sterlization Technologies LLC Due to The wrong sterilization time was on the label....

Date: February 3, 2014
Company: Innovative Sterlization Technologies LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Innovative Sterlization Technologies LLC directly.

Affected Products

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

Quantity: M2104 - 25 units; M2408 - 84 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Innovative Sterlization Technologies LLC

Innovative Sterlization Technologies LLC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report