Stop using nowMedical device recall · FDA · Published June 24, 2021
CardioQuip MCH-10RMS Cooler-Heater Module: Bacterial Contamination Risk in Surgery
CardioQuip recalls MCH-10RMS refrigeration modules used in surgery due to potential bacterial growth in water systems that could infect patients during procedures.
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
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Contact the company
📍Recalling firmCardioQuip, LLC8422 Calibration Ct · College Station, TX 77845-5328
“CardioQuip MCH-10RMS Cooler-Heater Module: Bacterial Contamination Risk in Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62305-cardioquip-mch-10rms-cooler-heater-module-bacterial-contamination-risk-in. Based on FDA recall #Z-0069-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0069-2022%22&limit=1).
The FDA announced on June 24, 2021, that CardioQuip, LLC is recalling its Modular Cooler-Heater 1000(i) Refrigeration Module due to the potential for bacterial growth. This contamination could aerosolize during surgery and cause patient infection.
The FDA stated there is potential for bacteria, including Nontuberculous mycobacterial (NTM), to grow in the water system of these heater-cooler devices. This could result in contaminated water being aerosolized into the operating room during surgery, potentially causing patient infection.
Context
GovInfoNow's records show CardioQuip, LLC has issued three other recalls since May 12, 2021. On October 24, 2023, the company recalled the MCH-1000(m) Cooler-Heater due to bacterial contamination risk. Other recent recalls of similar products include ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), Medtronic GUNDRY Cannula Recall (April 21, 2026), and Medtronic DLP Cannula Recall (April 21, 2026).
How to tell if you have this one
Check for the model MCH-10RMS with serial numbers starting with (01)00860000846127. These modules are used with heat exchange devices in surgical settings.
Brand
CardioQuip
Product
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Immediately
Discontinue use of the recalled MCH-10RMS refrigeration module to prevent potential patient exposure to contaminated water.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 37 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of TX, PA, FL, CA, HI, SC, OH, AK, NY, IL, AR, WI, MI, AL, KS, NJ, GA, AZ, KY, MS, TN, LA, DE, MA, VA, CO, NE, NC, NH, ME, WV, PA, MO, MN, IN, CT, NH, NV, UT and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 4 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0069-2022 (June 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0069-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.