Cincinnati Sub-Zero Products LLC, a Gentherm Company

Complete recall history across all FDA and CPSC categories — 8 total recalls

Cincinnati Sub-Zero Products LLC, a Gentherm Company appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (8)

FDA medical device enforcement actions by Cincinnati Sub-Zero Products LLC, a Gentherm Company

Date Product Reason Class
Jul 19, 2019 MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to... Updated Manual-Warnigs have been added stating that exceeding 40'C for extend... Class III
Jul 2, 2019 Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage... Warnings statements have been added- exceeding 40 degree C for extended perio... Class II
Jul 2, 2019 Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature ... Warnings statements have been added- exceeding 40 degree C for extended perio... Class II
Jul 2, 2019 CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool ... Warnings statements have been added- exceeding 40 degree C for extended perio... Class II
Jun 20, 2019 Norm-O-Temp model 111W The manual does not provide instruction stating that exceeding 40 Celsius for... Class II
Jun 20, 2019 Norm-O-Temp model 111Z The manual does not provide instruction stating that exceeding 40 Celsius for... Class II
Dec 19, 2018 Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: ... Evidence supports that when customers performed a fuse replacement as part of... Class II
Sep 4, 2018 Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Rese... Potential for membrane (control panel) switch errors leading to an inability ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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