The Recall Desk

Manufacturer

Cincinnati Sub-Zero Products LLC, a Gentherm Company

8 recalls in our database name Cincinnati Sub-Zero Products LLC, a Gentherm Company as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2019-11-27

Of the 8 recalls from Cincinnati Sub-Zero Products LLC, a Gentherm Company we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

  • HighFDA (Devices)·Z-0418-2020·2019-11-27

    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.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2020·2019-11-27

    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.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0417-2020·2019-11-27

    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.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2356-2019·2019-09-11

    Norm-O-Temp 111W Medical Device Recalled for Missing Tissue Damage Warning

    Cincinnati Sub-Zero Products LLC is recalling Norm-O-Temp model 111W units because the manual lacks instructions warning that exceeding 40 Celsius for extended periods can cause tissue damage.

    Product
    Norm-O-Temp model 111W
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2355-2019·2019-09-11

    Norm-O-Temp 111Z Medical Device Recalled for Missing Tissue Damage Warning

    Cincinnati Sub-Zero Products LLC is recalling Norm-O-Temp model 111Z devices because the manual lacks instructions warning that exceeding 40 Celsius for extended periods can cause tissue damage.

    Product
    Norm-O-Temp model 111Z
    Category
    Medical Device
    Distribution
    42 states
  • LowFDA (Devices)·Z-2291-2019·2019-08-28

    FDA Recalls MICRO-TEMP LT Heat Therapy Systems Due to Tissue Damage Risk

    Cincinnati Sub-Zero is recalling 2,079 MICRO-TEMP LT heat therapy systems because updated warnings indicate that exceeding 40°C for extended periods may cause tissue damage.

    Product
    MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0825-2019·2019-02-20

    Hemotherm CE Dual Reservoir Cooler/Heater Recalled for Overheating Risk

    Cincinnati Sub-Zero is recalling 396 Hemotherm CE Dual Reservoir Cooler/Heater units because fuse clips may stretch, causing overheating and device shutdown.

    Product
    Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0063-2019·2018-10-10

    Hemotherm 400CE Recalled for Control Panel Switch Errors

    Cincinnati Sub-Zero is recalling 270 Hemotherm 400CE devices due to potential control panel switch errors that may prevent setting changes or cause unintended changes.

    Product
    Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass pr
    Category
    Medical Device
    Distribution
    Distributed nationwide