[pending] Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applicat
Pending LLM rewrite. Source: FDA_DEVICE Z-1455-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Complaints of the ceramic tip of the resection sheath breaking have been received.
The recalled product
- Product
- Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. A2641
- UDI: 04042761004060
- All Lots.
Distribution
Distributed nationwide across the United States.
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