Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/C
- 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
7 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.