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Olympus Corporation of the Americas: Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.

Medical DevicesSource: FDA (device) · Date: 2026-03-04

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Olympus Corporation of the Americas
Product
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Reason / hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide Distribution.
Recall initiated
2025-11-11
Code info
Model No. A22040A; UDI: 04042761029339; All Lots.
Product quantity
6,949 units
Voluntary mandated
Voluntary: Firm initiated
City
Center Valley
State
PA
Country
United States
Event id
98288
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