CardioQuip MCH-1000(i) Cooler-Heater Recall: Water Quality Labeling Missing

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

CardioQuip is recalling its MCH-1000(i) modular cooler-heaters because the product lacks instructions for proper water quality maintenance and device inspections. This could lead to improper use if users 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 perform these steps correctly, potentially causing issues like poor water quality or device malfunction.

Who’s affected

Owners of CardioQuip MCH-1000(i) modular cooler-heaters with serial numbers listed in the recall are affected. Users who maintain the device without proper water quality guidance are at slightly higher risk.

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
Category
Medical device

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.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is due to missing labeling for proper water-quality maintenance and device inspection instructions.

How can I tell if my product is affected?

Check for the model MCH-1000(i), CE 2797, and serial numbers starting with (01)00860000846103.

What should I do if I have this product?

The recall does not specify a remedy, so contact CardioQuip directly for guidance on water quality maintenance.

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-0035-2022 — CardioQuip CardioQuip

Hello,

I own a CardioQuip that is covered by recall Z-0035-2022 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-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.

CardioQuip, LLC recalls CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103

Lower-risk recall