Agency classClass IIOur severity:High FDA (Devices)·Z-0418-2020·Announced 2019-11-27

Cincinnati Sub-Zero Recalls Blanketrol II Hyper-Hypothermia Systems

Cincinnati Sub-Zero is recalling 3,726 Blanketrol II Hyper-Hypothermia Systems to add warnings about potential tissue damage from extended high temperatures.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of tissue damage (burns) from extended high temperatures. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported in the source text.

Plain-English summary

Cincinnati Sub-Zero Products LLC, a Gentherm Company, is recalling 3,726 units of the Blanketrol II Hyper-Hypothermia System, Models 222R and 222S. The recall covers units distributed worldwide, including the United States and numerous international locations. The affected serial numbers for Model 222R range from 071-18490 through 123-20534, and for Model 222S from 104-2-00001 through 161-2-01848.

The recall was initiated to add warning statements to the product documentation. The 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 source text does not specify the exact corrective action consumers or healthcare facilities should take, such as whether to stop using the device or contact the manufacturer for updated documentation. Users should refer to the official FDA recall notice for specific instructions on how to proceed.

The recalled product

Product: Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - 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 — Thermal Therapy
Hazard: burn-injury
tissue-damage
Affected units: 3,726

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

See all →

High
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FDA (Devices) · 2019-11-27
Moderate
Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System Recall for Warning Updates
FDA (Devices) · 2019-11-27
High
Norm-O-Temp 111W Medical Device Recalled for Missing Tissue Damage Warning
FDA (Devices) · 2019-09-11
High
Norm-O-Temp 111Z Medical Device Recalled for Missing Tissue Damage Warning
FDA (Devices) · 2019-09-11
Low
FDA Recalls MICRO-TEMP LT Heat Therapy Systems Due to Tissue Damage Risk
FDA (Devices) · 2019-08-28

Same hazard · burn injury