Everest Bipolar Cutting Forceps and Gyrus Bipolar Cutting Forceps

• 5 recalls, same reason

  • Ongoing Z-1642-2026 FDA Class II ·initiated 25 Feb 2026
  • Ongoing Z-1644-2026 FDA Class II ·initiated 25 Feb 2026
  • Ongoing Z-1643-2026 FDA Class II ·initiated 25 Feb 2026
  • Ongoing Z-1639-2026 FDA Class II ·initiated 25 Feb 2026
  • Ongoing Z-1638-2026 FDA Class II ·initiated 25 Feb 2026

  Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

• 3 recalls, same reason

  • Ongoing Z-2541-2024 FDA Class II ·initiated 1 Jul 2024
  • Ongoing Z-2540-2024 FDA Class II ·initiated 1 Jul 2024
  • Ongoing Z-2542-2024 FDA Class II ·initiated 1 Jul 2024

  Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

510(k) Number

K023492 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Gyrus Endourology System: Axipolar Resectoscope Electrode

  Class II

  FDA 510(k) K994166 Active Cleared 27 Dec 1999

• Gyrus Open Forceps

  Class II

  FDA 510(k) K024286 Active Cleared 17 Nov 2003

• Everest LP Bipolar Scissors and Gyrus LP Bipolar Scissors

  Class II

  FDA 510(k) K031081 Active Cleared 21 May 2003

• Zip Open Forceps with Electrosurgical Cut

  Class II

  FDA 510(k) K020585 Active Cleared 13 Jul 2002

• Gyrus Plasma Skin Resurfacing System

  Class II

  FDA 510(k) K041999 Active Cleared 2 Mar 2005

• Plasmakinetic Endourology System

  Class II

  FDA 510(k) K003569 Active Cleared 19 Dec 2000

See all devices from Gyrus Medical, Ltd. →