Quick Facts at a Glance
- Recall Date
- October 31, 2025
- Hazard Level
- HIGH
- Brand
- Aizu Olympus
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Aizu Olympus
- Product type
- OER-Elite Medical Device
- Model numbers
- OER-Elite
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 31, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Aizu Olympus Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
About This Product
The OER-Elite is a medical device manufactured by Aizu Olympus Co. It is used in clinical settings under professional supervision.
Industry Context
This recall is not indicated to be part of a broader industry pattern.
Real-World Impact
Active recall with nationwide distribution means facilities and patients must halt use and await instructions. No injuries reported in the notice.
Practical Guidance
How to identify if yours is affected
- Verify device model is OER-Elite
- Confirm Serial: All and quantity 6578 units
- Confirm device distribution in the United States
Where to find product info
Check the device label, packaging, and the FDA enforcement recall page provided in the notice.
What timeline to expect
Timeline for remedy is not specified in the recall notice.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- File a complaint with the FDA if the manufacturer remains unresponsive.
- Keep copies of all correspondence and recall notices.
How to prevent similar issues
- When purchasing medical devices, verify UDI and model numbers.
- Look for manufacturer recalls and regulatory notices before deployment.
- Establish a process to stop use immediately when a recall is announced.
Documentation advice
Retain the recall notice, device labels showing model and UDI, and all correspondence with the manufacturer and healthcare providers.
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Product Details
Model: OER-Elite; UDI: 04953170404047; Serial #: All; Sold in: United States nationwide; Sold from: Unknown; Price: Unknown; Quantity: 6578; Recall date: 2025-10-31; Manufacturer: Aizu Olympus Co.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
- Recall date: 2025-10-31; Report date: 2025-12-10
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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