Agency classClass IIOur severity:High FDA (Devices)·Z-1640-2026·Announced 2026-04-01

Olympus PK cutting forceps jaws may break from defective welds

Olympus is recalling PK Cutting Forceps because a supplier did not adequately validate the welding process, and defective welds can cause the forceps jaw to break during clinical use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the jaw may break inside a patient during a surgical procedure, and no injuries are stated in the source.

Plain-English summary

Olympus Corporation of the Americas is recalling the Olympus PK Cutting Forceps, 5 mm 33 cm, model PK-CF0533. The device generates and applies radio-frequency alternating current to soft tissues for cutting and coagulation during endoscopic or open surgical procedures. About 444 units were distributed nationwide in the United States and to Canada, Mexico, the EU, Australia, China, Singapore, Korea and Japan. The FDA has classified this recall as Class II.

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 forceps' jaw breaking during clinical use.

All unexpired lot numbers are affected. The device carries UDI 00821925035867.

Facilities can identify affected forceps by the model number and UDI above, and may contact Olympus Corporation of the Americas for further information.

The recalled product

Product: Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation…
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Electrosurgical instrument
Hazard: weld-defect
jaw-breakage
surgical-risk
Affected units: 444

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Model: PK-CF0533
UDI: 00821925035867
Lot Numbers: All unexpired

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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