Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar
- Recall date
- 2026-04-01
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Recommended action
What to do
164 units
Product description
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.