HIGH

Olympus Inner Sheath Recalled Over Breaking Ceramic Tip Hazard

Olympus Corporation of the Americas recalled 437 units of the Inner Sheath, Model No. WA22017A, on November 11, 2025. The recall follows complaints of the ceramic tip breaking during use, posing a significant risk to patients. Healthcare providers and patients should cease use immediately and follow the manufacturer’s instructions.

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
Unknown
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 Inner Sheath Model No. WA22017A is used in urological and gynecological procedures to facilitate various medical interventions. Healthcare professionals utilize these sheaths for their precision and reliability during surgeries.

Why This Is Dangerous

The ceramic tip of the resection sheath can break during medical use, potentially causing complications for patients. This defect poses a significant risk during critical procedures where device integrity is essential.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects healthcare providers and patients who rely on this device for medical procedures. Immediate cessation of use is necessary to prevent potential injuries.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the device.
  2. Verify the UDI number if available.
  3. Contact Olympus for confirmation if uncertain.

Where to find product info

Look for the model number on the device packaging or the product itself, typically located near the manufacturer's label.

What timeline to expect

Expect a refund processing timeline of approximately 4-6 weeks after submission of the recall form.

If the manufacturer is unresponsive

  • Document all correspondence with Olympus.
  • Reach out to the FDA for further guidance.
  • Consider consulting a legal professional if necessary.

How to prevent similar issues

  • When purchasing medical devices, look for safety certifications and clear usage instructions.
  • Stay updated on recalls from manufacturers and regulatory bodies.
  • Consult with healthcare providers about alternative devices.

Documentation advice

Keep records of all communications regarding the recall, including emails, letters, and any receipts related to the product.

Product Details

The recalled product is the Olympus Inner Sheath, Long, Model No. WA22017A. It is designed for urological and gynecological applications. The device was distributed nationwide in the U.S.

Key Facts

  • 437 units recalled
  • Ceramic tip can break during use
  • Risk of complications for patients
  • Follow recall instructions 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 Classification

Product Details

Model Numbers
Model No. WA22017A
UDI: 04042761051514
All Lots.
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

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