BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.

    Recall: Z-1641-2026 · Initiated February 25, 2026

    Recall

    Recall Number
    Z-1641-2026
    Event Number
    98454
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 25, 2026
    Posted
    March 25, 2026
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.

    Reason

    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.

    Action

    On February 25, 2026 URGENT: MEDICAL DEVICE REMOVAL letters were sent to customers. Actions to be taken: 1. Examine inventory and quarantine any affected devices 2. Cease usage of the product with immediate effect 3. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization 4. Even if you no longer have the device, Olympus requests that you acknowledge receipt of this letter through the Olymps portal 5. Please forward this notice to other users who may have the affected products if you have further distributed it.

    Distribution

    Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.

    Quantity

    2648 units