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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/Surgical Equipment

Olympus Endoscope Valves and Reprocessors Recalled for Compatibility Defect

Agency Publication Date: March 20, 2026
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Summary

Olympus Corporation of the Americas has recalled 143,245 medical device components because the MAJ-1443 suction valves and MAJ-1444 air/water valves are no longer compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. This incompatibility means the valves may not be properly cleaned and disinfected between uses. The recall affects four specific models of valves and reprocessors distributed nationwide.

Risk

Reprocessing incompatibility can lead to ineffective sterilization of the valves. If these components are not properly disinfected, there is a risk of cross-contamination and the spread of infections between patients during endoscopic procedures.

What You Should Do

  1. Identify if you have the affected Olympus equipment by checking the model and catalog numbers on your device labels or packaging.
  2. For suction valves, look for Model MAJ-1443 (Catalog N5363430). For air/water valves, look for Model MAJ-1444 (Catalog N5363530).
  3. For reprocessors, look for OER-Elite Model N5789340 or OER-Pro Model N3058140.
  4. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  5. If you have additional questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

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

Affected Products

Product: Olympus Endoscope Suction Valve - MAJ-1443
Model / REF:
MAJ-1443
Lot Numbers:
All Lot/Serial Numbers
UDI:
04953170355912

Catalog Number: N5363430; Recall #: Z-1610-2026

Product: Olympus Endoscope Air/Water Valve - MAJ-1444
Model / REF:
MAJ-1444
Lot Numbers:
All Lot/Serial Numbers
UDI:
04953170355929

Catalog number: N5363530; Recall #: Z-1611-2026

Product: Olympus Endoscope Reprocessor OER-Elite
Model / REF:
N5789340
Lot Numbers:
All Lot/Serial Numbers
UDI:
04953170404047

Catalog number: N5789340; Recall #: Z-1612-2026

Product: Olympus Endoscope Reprocessor OER-Pro
Model / REF:
N3058140
Lot Numbers:
All Lot/Serial Numbers
UDI:
04953170258589

Catalog Number: N3058140; Recall #: Z-1613-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98371
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Authorized Medical Distributors; Direct Sales
Manufactured In: United States
Units Affected: 4 products (47,383 units; 89,579 units; 2,929 units; 3,354 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 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.