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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 Cystoscope Outer Sheath Recalled for Tip Damage and Incompatibility

Agency Publication Date: February 20, 2026
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Summary

Olympus Corporation of the Americas is recalling 633 units of the Olympus Cystoscope Outer Sheath (Model WA22810A) because it is incompatible with the GreenLight Laser used for BPH (enlarged prostate) therapy. Using these devices together can cause the tip of the cystoscope to become damaged during a procedure. Olympus is removing these products from service to prevent potential patient harm or device failure during surgery.

Risk

The incompatibility between the sheath and the laser can damage the device's tip while it is inside a patient, potentially leading to surgical delays, the presence of device fragments in the body, or injury to the urinary tract.

What You Should Do

  1. Stop using the recalled Olympus Cystoscope Outer Sheath immediately.
  2. Identify your device by checking for Model/Catalog number WA22810A and Model number WA2280A with UDI 04042761051729. All lots of these models are affected.
  3. Contact Olympus Corporation of the Americas or your distributor to arrange for the return, replacement, or correction of the device.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

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 Cystoscope Outer Sheath
Model / REF:
WA22810A
WA2280A
Lot Numbers:
All lots
UDI:
04042761051729

Recalled due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98300
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: authorized medical distributors; direct sales
Manufactured In: United States
Units Affected: 633 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.