RegWardenFDA facility compliance records
Facility

SCOTTCARE CORPORATION

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

Activity by year

FDA actions on record by year2016: 1 recalls; 2017: 1 inspections1201612017201820192020202120222023202420252026
  • Recalls (1)
  • Inspections (1)

Devices registered here (3)

  • Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
    Product code DRT (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2300
  • Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
    Product code MWI (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2300
  • Transmitters And Receivers, Physiological Signal, Radiofrequency
    Product code DRG (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2910

Recalls & enforcement

FDA inspections (1)

  • VAI2017-10-05
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: 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. “SCOTTCARE CORPORATION (FEI 1527715) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1527715-scottcare-corporation/

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