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Cincinnati Sub-Zero Products Inc

Complete recall history across all FDA and CPSC categories — 6 total recalls

Cincinnati Sub-Zero Products Inc 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 (6)

FDA medical device enforcement actions by Cincinnati Sub-Zero Products Inc

Date Product Reason Class
Mar 9, 2017 Hemotherm CE, model 400CE, Heater-Cooling Device Improperly rated fuses were used in the manufacture of the device. Class II
Nov 7, 2016 The Hemotherm 400CE 115v, containing power board p/n 39945 The device may not maintain water flow or temperature control. Class II
Jan 7, 2015 Cold Therapy Pad - cold water circulating pad, one unit per package. The pa... Seals in the water path of the CT-99 cold therapy pad may separate during use... Class II
Jan 8, 2014 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or ... The incorrect voltage component was placed into the device during manufacturi... Class II
Sep 3, 2013 Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 M... During a label review it was discovered that both the Blanketrol III Operatio... Class II
May 15, 2013 Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data E... During a customer inquiry regarding a beta version of the Bill Data Export S... 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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