CardioQuip, LLC

Complete recall history across all FDA and CPSC categories — 9 total recalls

CardioQuip, LLC 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 (9)

FDA medical device enforcement actions by CardioQuip, LLC

Date Product Reason Class
Oct 24, 2023 CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A There is the potential that cooler-heater devices may contain bacterial conta... Class II
Oct 24, 2023 CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A There is the potential that cooler-heater devices may contain bacterial conta... Class II
Oct 19, 2023 CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A There is a potential for the heating-chamber to malfunction resulting in melt... Class II
Oct 19, 2023 CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A There is a potential for the heating-chamber to malfunction resulting in melt... Class II
Jun 24, 2021 CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-1... There is the potential bacterial including Nontuberculous mycobacterial (NTM)... Class II
May 12, 2021 CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, C... Labeling does not include guidance for proper water-quality maintenance and ... Class II
May 12, 2021 CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE ... Labeling does not include guidance for proper water-quality maintenance and ... Class II
May 12, 2021 CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: ... Labeling does not include guidance for proper water-quality maintenance and ... Class II
May 12, 2021 CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)0086... Labeling does not include guidance for proper water-quality maintenance and ... 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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