OneTray Sealed Sterilization Containers Recalled for Incorrect Labeling
Innovative Sterilization Technologies LLC is recalling OneTray Sealed Sterilization Containers because the labels list the wrong steam sterilization time.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error regarding sterilization parameters. This fits the rubric for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Innovative Sterilization Technologies LLC is recalling OneTray Sealed Sterilization Containers. These are rigid containers used to steam sterilize medical devices. The recall involves specific units of models M2104 and M2408.
The recall was initiated because the product labels contain incorrect sterilization time information. The labels list "Steam Gravity 10 - 34 minutes at 270 degrees F" instead of the correct "Steam Gravity 17 - 34 minutes at 270 degrees F."
The affected units were distributed nationwide in Illinois, Indiana, Louisiana, Ohio, Pennsylvania, Texas, and West Virginia. Users should stop using the affected containers and contact the manufacturer for instructions.
The recalled product
- Product
- OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
- Manufacturer
- Innovative Sterlization Technologies LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- M2104 Lot # 044305
- 044379
- 044380 & 044418. M2408 Lot # 044296
- 022304
- 044381
- 044420
- 044421 & 044422.
Distribution
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