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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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High RiskFDA Device
Medical Devices/Diagnostic Equipment

Olympus Corporation of the Americas: Water Filters Recalled Due to Assembly Error and Infection Risk

Agency Publication Date: February 7, 2024
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Summary

Olympus has recalled 877 MAJ-2318 water filters, as well as 119 OER-Elite and 3 OER-MINI endoscope reprocessors that may contain these filters. The water filters may have been assembled incorrectly, which allows unfiltered tap water to be used during the medical device cleaning process. This defect can lead to endoscopes remaining contaminated after cleaning, which may expose patients to serious health risks. Consumers and healthcare facilities should immediately identify if they are using the affected lots and contact the manufacturer for guidance.

Risk

Unfiltered tap water used during the cleaning process may leave medical devices contaminated with bacteria or other pathogens, potentially causing serious infections or sepsis in patients.

What You Should Do

  1. Check your inventory for Water Filter MAJ-2318, or OER-Elite and OER-MINI endoscope reprocessors that may contain these filters.
  2. Verify the identifying information on your product packaging or the filter itself for UDI-DI 04953170401473 and look for Lot numbers 36A, 37A, or 38A.
  3. If you identify an affected water filter or reprocessor unit, contact your healthcare provider or Olympus Corporation of the Americas to determine the next steps for inspection or replacement.
  4. For further instructions regarding potential refunds or replacement parts, contact Olympus Corporation of the Americas at their Center Valley, Pennsylvania headquarters at 3500 Corporate Pkwy, Center Valley, PA 18034-8229.
  5. If you have additional questions or concerns, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Water Filter MAJ-2318
Model / REF:
MAJ-2318
Z-1009-2024
UPC Codes:
04953170401473
Lot Numbers:
36A
37A
38A
Product: OER-Elite Endoscope Reprocessor
Model / REF:
OER-Elite
UPC Codes:
04953170401473
Lot Numbers:
36A
37A
38A
Product: OER-MINI Endoscope Reprocessor
Model / REF:
OER-MINI
UPC Codes:
04953170401473
Lot Numbers:
36A
37A
38A

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93792
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Olympus Corporation of the Americas
Manufactured In: United States
Units Affected: 877 MAJ-2318, 119 OER-Elite, 3 OER-MINI
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 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.