RELI GC6354-BRCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00386120005379), received between Jan 31, 2019 and Jan 31, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ORAL SURGERY, THE SUTURE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE WAS REPORTED TO HAVE DETACHED FROM SEVERAL SUTURES USED BY THE CLINICIAN. THERE WAS NO HARM CAUSED TO THE PATIENT IN THESE INSTANCES AND THE NEEDLE WAS RETRIEVED WITHOUT ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8292961 ↗