Recall Z-0660-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Kirwan Surgical Products, LLC
Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip oute
| Date | Dec 16, 2024 (initiated Nov 14, 2024) |
| Status | Open, Classified |
| Reason | Potential for the outer stainless-steel tube to break or detach. |
| Root cause | Device Design |
| Action | Kirwan Surgical Products notified customers on 11/14/2024 via URGENT MEDICAL DEVICE RECALL letter. Customers were instructed to return any affected units, notify all customer if affected product was further distributed and request they return them, and complete and return the Response Form provided in the notification. |
| Quantity | 2,999 units |
| Distribution | Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K864402 | BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE New England Surgical Instrument Corp., Jan 20, 1987 |