CARDIOCOMMAND, INC.
2 recall(s) on record — most severe on record: Class III.
Activity by year
- Recalls (2)
- Inspections (3)
Devices registered here (1)
- Stethoscope, Esophageal, With Electrical ConductorsProduct code BZT (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.1920
Recalls & enforcement
- Class IIITerminated2019-06-24There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.
- Class IIITerminated2019-05-10Possible corrosion of the battery contact(s).
FDA inspections (3)
- VAI2026-07-30Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
- VAI2022-12-09Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
- NAI2017-05-17No 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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