GEM BiPolar Jewelers Forceps GEM4025J-NS-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844735006049), received between Jan 8, 2026 and Jan 8, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Arcing” (1 report).

1 other recall cover devices cleared under the same FDA submission (K130669); they may or may not involve this specific model.

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 18, 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 8, 2026Arcing

  COMPLAINANT ALLEGES "I RECEIVED A CALL WITH OUR CUSTOMER STATING THAT ALL 14 GEM BI-POLARS RECENTLY PURCHASED ARE NOT CAUTERIZING, SPARKING AND WILL NOT WORK CORRECTLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012697 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130669. One submission often covers many models, so check the product and lot details in each record.

• Z-1944-2018 · May 11, 2018 · Terminated
  Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 (b1) Insulated Irrigating Bayonet Forceps 6.25" (15