CardioQuip MCH-11TEC Cooler-Heater Recall: Water Quality Labeling Missing

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Recalling firmCardioQuip, LLC8422 Calibration Ct · College Station, TX 77845-5328

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

CardioQuip is recalling its MCH-11TEC modular cooler-heaters because the product lacks clear instructions for water quality maintenance and device inspections. This could lead to improper use if owners don't follow necessary maintenance steps.

Why it’s dangerous

The device requires specific water quality maintenance and regular inspections to function safely. Without clear labeling, users might not know how to maintain water quality, potentially causing minor operational issues.

Who’s affected

Owners of CardioQuip MCH-11TEC modular cooler-heaters with serial numbers starting with (01) 00860000846134 are affected. Those who use the device without proper water quality checks may face minor issues.

How to tell if you have this one

Check for the model MCH-11TEC with serial numbers starting with (01) 00860000846134. The product was sold with CE 2797 certification.

Brand
CardioQuip
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Verify your unit's serial number starts with (01) 00860000846134 to confirm it's affected.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is for missing water quality maintenance instructions and device inspection guidance, which could lead to improper use.

What should I do if I have this product?

Check your serial number to see if it's affected; the recall doesn't require immediate action beyond verification.

Is there a fix for this issue?

The recall record does not mention any remedy or fix for this issue.

Take action

Contact CardioQuip

We’ve drafted a message you can send CardioQuip to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0038-2022 — CardioQuip CardioQuip

Hello,

I own a CardioQuip that is covered by recall Z-0038-2022 from CardioQuip.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

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-0038-2022 (May 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0038-2022 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.

CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134

Lower-risk recall