Olympus Corporation of the Americas: Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Read the official notice at FDA (device) →
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. A22040T. 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. A22040T; UDI: 04042761029360; All Lots.
- Product quantity
- 7,426 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Center Valley
- State
- PA
- Country
- United States
- Event id
- 98288
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