RegWardenFDA facility compliance records
Recall

Class II — CardioQuip, LLC

Recalling firmCardioQuip LLC
Registered facilityCardioQuip (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonThere is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
ProductCardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
Quantity150 units
DistributionUS Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA
Initiated2023-10-19
Classified2023-12-01
Recall numberZ-0438-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — CardioQuip, LLC (Z-0438-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93347/

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