Recall Register

Cincinnati Sub-Zero Products LLC, a Gentherm Company: FDA recalls

FDA enforcement reports name Cincinnati Sub-Zero Products LLC, a Gentherm Company as the recalling firm in 5 events. The events have 8 product records. The recalls started from 2018 to 2019. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

5 events, newest first.

FDA enforcement events of Cincinnati Sub-Zero Products LLC, a Gentherm Company
InitiatedProduct (first record)TypeClassRecordsStatus
19 Jul 2019MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.DeviceClass III1Terminated
2 Jul 2019Blanketrol 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.DeviceClass II3Terminated
20 Jun 2019Norm-O-Temp model 111ZDeviceClass II2Terminated
19 Dec 2018Hemotherm 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 blood during cardiopulmonary bypass…DeviceClass II1Terminated
4 Sep 2018Hemotherm 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 procedures lasting six hours or less. The…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Cincinnati Sub-Zero Products LLC, a Gentherm Company: events for each product type
TypeEvents
Device5
Cincinnati Sub-Zero Products LLC, a Gentherm Company: events in each class
ClassEvents
Class II4
Class III1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Cincinnati Sub-Zero Products LLC, a Gentherm Company, by the year that the recall started. The largest year is 2019, with 3 events.

Official channels

Cite this page

Recall Register. Cincinnati Sub-Zero Products LLC, a Gentherm Company: FDA recalls. https://recallregister.com/firm/cincinnati-sub-zero-products-llc-a-gentherm-company/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
OH

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Cincinnati Sub-Zero Products LLC, a Gentherm Company have?
Class II: 4 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Cincinnati Sub-Zero Products LLC, a Gentherm Company?
FDA event 83387, which the firm started on 19 Jul 2019. The first product in the record is: MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
How many FDA recalls of Cincinnati Sub-Zero Products LLC, a Gentherm Company have the status Ongoing?
No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.