Lower riskMedical device recall · FDA · Published May 12, 2021
CardioQuip MCH-1000(i) Cooler-Heater Recall: Water Quality Labeling Missing
CardioQuip recalls MCH-1000(i) modular cooler-heaters due to missing water quality maintenance instructions. Owners should check serial numbers and contact for guidance.
“CardioQuip MCH-1000(i) Cooler-Heater Recall: Water Quality Labeling Missing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62549-cardioquip-mch-1000-i-cooler-heater-recall-water-quality-labeling. Based on FDA recall #Z-0035-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0035-2022%22&limit=1).
CardioQuip, LLC recalled the Modular Cooler-Heater Model MCH-1000(i) due to labeling that lacks proper water-quality maintenance and device inspection guidance. The FDA announced this voluntary Class II recall on May 12, 2021.
How to tell if you have it
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
UPC: 00860000846103
The hazard
The FDA stated the hazard is that labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Context
GovInfoNow's records show CardioQuip, LLC has had three other recalls since June 24, 2021. On October 24, 2023, the company recalled the MCH-1000(i) due to bacterial contamination risk, and on October 19, 2023, for a heating chamber melting risk. Other recent recalls of similar products include Medline Convenience Kits Recall: Temperature Probes May Have Distribution Error (May 28, 2026), Covidien Mon-a-Therm Temperature Probe Recall: Lack of FDA Clearance (April 23, 2026), and Medline Convenience Kits: Temperature Probe Recall Due to Distribution Error (May 28, 2026).
How to tell if you have this one
Check for the model MCH-1000(i), CE 2797, and serial numbers starting with (01)00860000846103. The product was sold with these identifiers.
Brand
CardioQuip
Product
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Germany, The Bahamas, Panama, Uruguay.
Recall number
Product, codes & lots
Quantity
Z-0035-2022
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103; All Serial numbers
1478 units
Z-0036-2022
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127; All Serial numbers
1380 units
Z-0037-2022
CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110; All Serial numbers
1646 units
Z-0038-2022
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134; All Serial numbers
369 uniyd
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the model number MCH-1000(i) and serial number starting with (01)00860000846103.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 49 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC,…” 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, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 5 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-0035-2022 (May 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0035-2022 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.