FDAHealthNovember 11, 2025
Olympus Corporation of the Americas — Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
⚠️ Complaints of the ceramic tip of the resection sheath breaking have been received.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 11, 2025
US Nationwide Distribution.
What's affected?
- Product
- Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
- Lot code
- s
Additional details
Model No. A22043A; UDI: 04042761021005; All Lots.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 118 units.
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