SCOTTCARE CORPORATION
1 recall(s) on record — most severe on record: Class II.
Activity by year
- 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, RadiofrequencyProduct code DRG (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2910
Recalls & enforcement
- Class IITerminated2016-02-25The firm received a complaint of the battery exploding while recharging.
FDA inspections (1)
- VAI2017-10-05Voluntary 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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