RegWardenFDA facility compliance records
Facility

PYRAMES INC

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

Activity by year

FDA actions on record by year2025: 1 recalls, 1 inspections20172018201920202021202220232024220252026
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • System, Measurement, Blood-Pressure, Non-Invasive
    Product code DXN (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1130

Recalls & enforcement

  • Class IIOngoing2025-02-24
    Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow…

FDA inspections (1)

  • NAI2025-12-08
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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. “PYRAMES INC (FEI 3014466900) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014466900-pyrames-inc/

Not open yet

Alerts for PYRAMES INC

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.