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Open, Classified

Olympus OER-Pro

FDA Recall Z-0873-2026 · Posted 2025-12-02

Recalling FirmAizu Olympus Co., Ltd.
Recall StatusOpen, Classified
Product CodeFEB
Date Initiated2025-10-31
Product Quantity6578 units

Reason for Recall

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

Firm Action

On October 31, 2025 URGENT Medical Device Safety Alert letters were sent to customers. Actions to be taken: 1. Olympus reminds users to follow the Warnings/Cautions and inspections outlined in all Olympus Endoscope Reprocessor Operation Manuals which are important to reduce the potential risk of fire to the device. 2. Carefully read the content of the notification. 3. Check your inventory for the reference devices and identify any in your inventory. 4. Ensure all personnel are completely knowledgeable and thoroughly aware of the contents of the letter. 5. Acknowledge receipt through the provided information. 6. Forward this notice if any affected product was further distributed.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103264ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PROOlympus Medical Systems Corporation · 2011-02-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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