Olympus OER-Pro (Aizu Olympus) – Maintenance Warning (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Olympus OER-Pro
Brand
Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan
Lot Codes / Batch Numbers
Model: OER-Pro, UDI: 04953170258589, Serial #: All
Products Sold
Model: OER-Pro; UDI: 04953170258589; Serial #: All;
Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan is recalling Olympus OER-Pro due to Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026