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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Olympus OER-Elite, OER-Pro, and OER-Mini Recalled for Maintenance Safety Info

Agency Publication Date: December 2, 2025
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Summary

Olympus is notifying customers about specific safety warnings, cautions, and updated maintenance schedules for several models of endoscope reprocessors, including the OER-Elite, OER-Pro, and OER-Mini. Approximately 6,578 units are affected by this voluntary recall, which emphasizes that only properly trained personnel should perform repairs and maintenance on these devices. These reprocessors are used in clinical settings to clean and disinfect medical endoscopes between patient uses.

Risk

Failure to follow the manufacturer's recommended maintenance schedules or allowing untrained personnel to perform repairs can result in device malfunction. This may lead to the inadequate disinfection of endoscopes, which poses a risk of patient-to-patient infection or exposure to harmful pathogens.

What You Should Do

  1. This recall affects Olympus OER-Elite, OER-Pro, and OER-Mini endoscope reprocessors manufactured by Aizu Olympus Co., Ltd.
  2. Identify your device by checking the model name and Unique Device Identifier (UDI) on the product label. Affected models include OER-Elite (UDI 04953170404047), OER-Pro (UDI 04953170258589), and OER-Mini (UDI 04953170331619). All serial numbers for these models are included.
  3. Review the pertinent warnings, cautions, and maintenance schedules provided in the manufacturer's notification letter.
  4. Ensure that all future repairs and scheduled maintenance are conducted exclusively by personnel who have been properly trained by Olympus.
  5. Stop using the recalled device and contact Olympus or your distributor to arrange for a review of your maintenance protocols or to schedule any necessary service.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or to report any device-related issues.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Olympus OER-Elite
Model / REF:
OER-Elite
Serial Numbers:
All
UDI:
04953170404047

Recall Number: Z-0872-2026

Product: Olympus OER-Pro
Model / REF:
OER-Pro
Serial Numbers:
All
UDI:
04953170258589

Recall Number: Z-0873-2026

Product: Olympus OER-Mini
Model / REF:
OER-Mini
Serial Numbers:
All
UDI:
04953170331619

Recall Number: Z-0874-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97849
Status: Active
Manufacturer: Aizu Olympus Co., Ltd.
Sold By: Olympus medical distributors; Direct sales from Aizu Olympus Co., Ltd.
Manufactured In: Japan
Units Affected: 3 products (6578 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.