Olympus Corporation of the Americas
Device Recalls (Class II)
Class II
Z-1445-2026
·
20260304
·
Ongoing
Product
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Reason for Recall
Complaints of the ceramic tip of the resection sheath breaking have been received.
Distribution
US Nationwide Distribution.
Source: openFDA Enforcement API