RELI GC1654-BRCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00386120005331), received between Oct 26, 2016 and Oct 26, 2016 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 26, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SUTURE NEEDLE BROKE NEAR THE SUTURE ATTACHMENT END WHILE PERFORMING A TOOTH EXTRACTION. THE PHYSICIAN TOOK AN X-RAY OF THE PATIENT'S MOUTH TO ENSURE NO NEEDLE FRAGMENT(S) WERE LEFT BEHIND. THE X-RAY CONFIRMED NO NEEDLE OR FRAGMENT WAS LEFT BEHIND IN THE PATIENT'S MOUTH. IT IS ASSUMED BY THE PHYSICIAN, THE NEEDLE OR FRAGMENT WAS CAPTURED BY SUCTION AS IT WAS NOT RECOVERED.

  Patient problems: No Information

  MAUDE report 6057753 ↗