RegWardenFDA facility compliance records
Facility

CARDIOCOMMAND, INC.

2 recall(s) on record — most severe on record: Class III.

Activity by year

FDA actions on record by year2017: 1 inspections; 2019: 2 recalls; 2022: 1 inspections; 2026: 1 inspections12017201822019202020211202220232024202512026
  • Recalls (2)
  • Inspections (3)

Devices registered here (1)

  • Stethoscope, Esophageal, With Electrical Conductors
    Product code BZT (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.1920

Recalls & enforcement

FDA inspections (3)

  • VAI2026-07-30
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2022-12-09
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2017-05-17
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Project Evaluation: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

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

Cite this record

RegWarden. “CARDIOCOMMAND, INC. (FEI 1927197) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1927197-cardiocommand-inc/

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