Z-1641-2026 Class II Ongoing
FDA device recall Z-1641-2026 was initiated by Olympus Corporation of the Americas on February 25, 2026 and is designated Class II. Reason for recall: 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 d… The recall status is ongoing. Affected quantity: 2648 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2026
- Initiation Date
- February 25, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2648 units
Product 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 for Recall
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.
Distribution Pattern
Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
Code Information
Model: HACF0533; UDI: 00821925036390; Lot Numbers: All unexpired;