Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0417-2020·Announced 2019-11-27

Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System Recall for Warning Updates

Cincinnati Sub-Zero is recalling 3,932 Blanketrol III Hyper-Hypothermia Systems to add warnings about tissue damage from extended high temperatures and clarify automatic mode usage.

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, but the source text describes the action as adding warnings and clarifications rather than reporting specific injuries or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cincinnati Sub-Zero Products LLC, a Gentherm Company, is recalling 3,932 units of the Blanketrol III Hyper-Hypothermia System, Model 233. The system is a body temperature management device composed of a heater, compressor, circulating pump, and blankets or pads. The recall covers serial numbers 071-3-00123 through 193-3-09498.

The recall was initiated to add warning statements to the product. Specifically, new warnings indicate that exceeding 40 degrees Celsius for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the system's Automatic modes.

The affected units were distributed worldwide, including the United States and numerous international locations. Consumers and healthcare facilities should stop using the affected systems and contact the manufacturer for instructions on how to obtain the updated warnings and clarifications.

The recalled product

Product: Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Manufacturer: Cincinnati Sub-Zero Products LLC, a Gentherm Company
Category: Medical Device — Temperature Management
Hazard: burn-injury
mis-labeling
Affected units: 3,932

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 (1)

Serial Numbers: 071-3-00123 through193-3-09498

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Cincinnati Sub-Zero Products LLC, a Gentherm Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Cincinnati Sub-Zero Products LLC, a Gentherm Company

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Same hazard · burn injury