HIGH

Olympus Resection Sheath Recalled Due to Breaking Tip Hazard

Olympus Corporation of the Americas recalled 2,626 units of its Resection Sheath on November 11, 2025. The ceramic tip of the sheath may break during use, posing a high risk to patients. Healthcare providers and patients must stop using the device immediately.

Quick Facts at a Glance

Recall Date
November 11, 2025
Hazard Level
HIGH
Brand
Olympus Corporation of the Americas
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Complaints of the ceramic tip of the resection sheath breaking have been received.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Olympus Resection Sheath is a medical device used in urologic applications. It is designed to assist in surgical procedures by allowing access to the urinary tract.

Why This Is Dangerous

The ceramic tip of the sheath may break during use, posing a risk of injury to patients undergoing procedures. This malfunction can lead to complications that require medical intervention.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers must stop using the device immediately, which may disrupt ongoing medical treatments and require alternative solutions.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the device to verify if it is Model No. A22041T.
  2. Inspect the packaging or documentation for any recall notice.
  3. Contact your healthcare provider for additional verification if uncertain.

Where to find product info

The model number and UDI can usually be found on the device packaging or the device itself near the manufacturer's label.

What timeline to expect

Expect a refund or replacement processing timeline of about 4-6 weeks.

If the manufacturer is unresponsive

  • Document all correspondence with Olympus Corporation.
  • Follow up via phone or email to ensure your request is being processed.
  • Consider reporting the issue to the FDA if there is no response.

How to prevent similar issues

  • Look for FDA recalls before purchasing medical devices.
  • Check for safety certifications when selecting medical products.
  • Consult with healthcare professionals about the reliability of devices used in procedures.

Documentation advice

Keep records of all communications, receipts, and any relevant documentation related to the recall.

Product Details

The recalled product is the Olympus Resection Sheath, 24 Fr., with Deflecting Obturator, Model No. A22041T. The affected model includes all lots and has been distributed nationwide in the U.S.

Key Facts

  • Model No. A22041T
  • Nationwide distribution in the U.S.
  • Ceramic tip may break during use
  • 2,626 units recalled
  • Stop using immediately

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Model No. A22041T
UDI: 04042761020978
All Lots.
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

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