RegWardenFDA facility compliance records
Facility

PLASMA SURGICAL INC.

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

Activity by year

FDA actions on record by year2012: 1 recalls; 2016: 1 inspections; 2025: 1 inspections1’12’13’14’151’16’17’18’19’20’21’22’23’241’25’26
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

  • Electrosurgical, Cutting & Coagulation & Accessories
    Product code GEI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4400

Recalls & enforcement

  • Class IITerminated2012-04-27
    Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use.

FDA inspections (2)

  • NAI2025-11-06
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2016-09-27
    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. “PLASMA SURGICAL INC. (FEI 3004754983) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004754983-plasma-surgical-inc/

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