FDA Medical devices recall ·
Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting… recall
- Recall number
- Z-1641-2026
- Date
- (initiated February 25, 2026)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2648 units
- Hazard tags
- Laceration
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model: HACF0533; UDI: 00821925036390; Lot Numbers: All unexpired;
Distribution
Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1641-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.