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U.S. Department of Health and Human Services

Class 2 Device Recall Endoscope Reprocessor OERMini

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 Class 2 Device Recall Endoscope Reprocessor OERMinisee related information
Date Initiated by FirmOctober 31, 2025
Date PostedDecember 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0874-2026
Recall Event ID 97849
510(K)NumberK120357 
Product Classification Accessories, cleaning, for endoscope - Product Code FEB
ProductOlympus OER-Mini
Code Information Model: OER-Mini; UDI: 04953170331619; Serial #: All;
Recalling Firm/
Manufacturer		 Aizu Olympus Co., Ltd.
3 Chome 1-1
Niiderakita
Aizuwakamatsu Japan
For Additional Information ContactCynthia Ow
647-999-3203
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce6578 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FEB
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