[pending] Olympus OER-Pro
Pending LLM rewrite. Source: FDA_DEVICE Z-0873-2026.
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
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
The recalled product
- Product
- Olympus OER-Pro
- Manufacturer
- Aizu Olympus Co., Ltd.
- 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: OER-Pro
- UDI: 04953170258589
- Serial #: All
Distribution
Distributed nationwide across the United States.
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