medical MODERATE Updated 2026-04-01

Olympus Corporation of the Americas recalls Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Na

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Recalled 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 during an endoscopic or open surgical procedure.

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model: PK-CF0533; UDI: 00821925035867; Lot Numbers: All unexpired;

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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