J-PLASMA® GS-018CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607151007812), received between Dec 22, 2016 and Apr 24, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2020Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  PATIENT REPORTED PAIN AND REDNESS ON HER FACE AFTER A DERMAL RESURFACING PROCEDURE. DERMAL RESURFACING IS AN OFF-LABEL USE OF THE DEVICE.

  Patient problems: Erythema; Injury; Pain; Patient Problem/Medical Problem; Skin Discoloration

  MAUDE report 9995171 ↗
• InjuryDec 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS NOTIFIED BE BOVIE MEDICAL SALE REPRESENTATIVE. A FACE AND NECK RESURFACING PROCEDURE WAS PERFORMED ON PATIENT WHO HAS SINCE COMPLAINED OF SCARING.

  Patient problems: Burn, Thermal

  MAUDE report 6200517 ↗