FDA DeviceClass IINotable

FDA Recall: Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog

Date: 2026-04-01
Brand: Olympus Corporation of the Americas
Category: Medical Device
FDA Class: Class II

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.

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.

Remedy

326 units

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