Olympus Cystoscope Outer Sheaths Recalled Due to Potential Tip Damage

Agency Publication Date: November 8, 2024

Summary

Olympus Corporation of the Americas is recalling 738 units of Olympus Cystoscope Outer Sheaths (models WA22810A and WA2280A). The company is removing the statement of compatibility with GreenLight Lasers for BPH therapy from the Instructions for Use because using a laser probe can damage the tip of the device. No injuries or incidents have been reported at this time.

Risk

Using a laser probe with these recalled sheaths can cause the tip of the device to sustain damage during use. This may lead to device failure or potential injury to the patient during medical procedures.

What You Should Do

This recall affects Olympus Cystoscope Outer Sheaths, models WA22810A and WA2280A, which are used in combination with rigid telescopes.
Check your clinical inventory for model numbers WA22810A and WA2280A with UDI 04042761051729. All lots for these models are included in this recall.
Stop using the recalled devices in any procedure involving GreenLight Lasers.
Contact Olympus Corporation of the Americas or your authorized distributor to arrange for updated instructions or to discuss return, replacement, or correction of your equipment.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information or questions regarding this recall.

Your Remedy Options

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

Outer sheaths can be combined with rigid Telescopes.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95584

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Direct distribution

Manufactured In: United States

Units Affected: 738 units

Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

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 · 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.

Summary

What You Should Do

This recall affects Olympus Cystoscope Outer Sheaths, models WA22810A and WA2280A, which are used in combination with rigid telescopes.

Check your clinical inventory for model numbers WA22810A and WA2280A with UDI 04042761051729. All lots for these models are included in this recall.

Stop using the recalled devices in any procedure involving GreenLight Lasers.

Contact Olympus Corporation of the Americas or your authorized distributor to arrange for updated instructions or to discuss return, replacement, or correction of your equipment.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information or questions regarding this recall.