Agency classClass IIOur severity:High FDA (Devices)·Z-0419-2020·Announced 2019-11-27

Cincinnati Sub-Zero Recalls CoolBlue Hyper-Hypothermia Systems for Tissue Damage Risk

Cincinnati Sub-Zero is recalling 5,291 CoolBlue Hyper-Hypothermia Systems because extended use above 40°C may cause tissue damage. Warning labels have been updated.

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 risk-of-harm product (tissue damage) where the hazard is explicitly stated in the updated warnings, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Cincinnati Sub-Zero Products LLC, a Gentherm Company, is recalling 5,291 units of the CoolBlue Hyper-Hypothermia System, Model Innercool. The system is a body hypothermia device composed of a heater, a compressor, a circulating pump, and blankets or pads. The recall affects serial numbers 073-CB-00001 through 162-CB-00294.

The recall was initiated because warnings statements have been added to the product documentation. Specifically, the updated warnings state 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 Automatic modes.

The affected products were distributed worldwide, including in the United States and numerous international locations. Consumers and healthcare facilities should stop using the affected units and contact the recalling firm for instructions on how to obtain the updated warning labels and clarifications.

The recalled product

Product: CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - 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: 5,291

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: 073-CB-00001 through 162-CB-00294

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
Cincinnati Sub-Zero Recalls Blanketrol II Hyper-Hypothermia Systems
FDA (Devices) · 2019-11-27
Moderate
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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