RegWardenFDA facility compliance records
Company

CardioQuip LLC

4 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2021: 2 recalls; 2023: 2 recalls201720182019202022021202222023202420252026
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2023-10-24
    There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
  • Class IIOngoing2023-10-19
    There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
  • Class IIOngoing2021-06-24
    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.
  • Class IIOngoing2021-05-12
    Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “CardioQuip LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10044068-cardioquip-llc/

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