[pending] Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 h
Pending LLM rewrite. Source: FDA_DEVICE Z-1489-2026.
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
Potential for rubber fragment detachment during use.
The recalled product
- Product
- Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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