[pending] Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Pending LLM rewrite. Source: FDA_DEVICE Z-1612-2026.
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
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
The recalled product
- Product
- Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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