Recall Z-1897-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Silex Medical, LLC
Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.
| Date | Jun 2, 2025 (initiated Jan 9, 2024) |
| Status | Open, Classified |
| Reason | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. |
| Root cause | Process control |
| Action | Silex formally notified customers on 01/09/2024. Instructions to consignees included to inspect all instruments that they received from the affected lots for the defect. If any instruments had the issue, the customers were instructed to send it back to their facility under an RGA. |
| Quantity | 6 units |
| Distribution | US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914910 | DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE) Davol, Inc., Jan 6, 1992 |