Z-1450-2026 Class II Ongoing
FDA device recall Z-1450-2026 was initiated by Olympus Corporation of the Americas on November 11, 2025 and is designated Class II. Reason for recall: Complaints of the ceramic tip of the resection sheath breaking have been received. The recall status is ongoing. Affected quantity: 437 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2026
- Initiation Date
- November 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 437 units
Product Description
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Reason for Recall
Complaints of the ceramic tip of the resection sheath breaking have been received.
Distribution Pattern
US Nationwide Distribution.
Code Information
Model No. WA22017A; UDI: 04042761051514; All Lots.