FDA Medical Device Recalls (openFDA)
Aizu Olympus Co., Ltd.: Olympus OER-Mini
- Recall number
- Z-0874-2026
- Recalling firm
- Aizu Olympus Co., Ltd.
- Product
- Olympus OER-Mini
- Status
- Open, Classified
- Initiated
- 2025-10-31
- Posted
- 2025-12-02
- Terminated
- not on file
- Reason
- Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- Root cause
- Under Investigation by 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.
- Quantity
- 6578 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Model: OER-Mini; UDI: 04953170331619; Serial #: All;
- 510(k) numbers
- ["K120357"]
- PMA numbers
- not on file
- Product code
- FEB
- Firm FEI
- 3002964398
- Firm city
- Aizuwakamatsu
- Firm state
- 3 Chome
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28