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Olympus Recalls Inner Sheath Due to Breaking Ceramic Tip Hazard

Olympus Corporation of the Americas recalled 1,141 units of the Inner Sheath, Model No. WA22017T, on November 11, 2025. The recall follows reports of the ceramic tip breaking, posing a high risk to patients. Healthcare providers and patients must stop using the device immediately and follow the manufacturer’s instructions.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
November 11, 2025
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Olympus Corporation of the Americas
Product type
Inner Sheath
Model numbers
Model No. WA22017T, UDI: 04042761051521, All Lots.
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    November 11, 2025

  2. Reported by FDA DEVICE

    March 4, 2026

  3. RecallRadar source check

    March 11, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

The Olympus Inner Sheath, Model No. WA22017T, is designed for use in urological and gynecological medical procedures. This device allows for the safe insertion and positioning of instruments during these sensitive applications.

Why This Is Dangerous

The ceramic tip of the resection sheath can break during use, which may compromise the safety of medical procedures and pose risks to patients. Such breakage could potentially lead to unintended injuries.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall may cause significant inconvenience for patients and healthcare providers who rely on this device in medical settings. Immediate action is necessary to prevent potential injuries.

Practical Guidance

How to identify if yours is affected

  1. Locate the model number on the device packaging.
  2. Check if the model number is WA22017T.
  3. Confirm if the device is part of all lots mentioned in the recall.

Where to find product info

The model number and UDI can typically be found on the device packaging or user manual.

What timeline to expect

Expect a refund or further instructions within 4-6 weeks after contacting the manufacturer.

If the manufacturer is unresponsive

  • Document all communication attempts with Olympus.
  • Reach out to your healthcare provider for assistance.
  • Consider filing a complaint with the FDA if no response is received.

How to prevent similar issues

  • Always verify if medical devices have been recalled before use.
  • Check for safety certifications and updates from manufacturers.
  • Follow proper handling instructions for medical devices.

Documentation advice

Keep records of all communications regarding the recall, including emails, letters, and notes from phone calls.

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Product Details

The recalled product is the Olympus Inner Sheath, Long; Model No. WA22017T. It is used for urological and gynecological applications. The product was distributed nationwide in the United States.

Key Facts

  • Recalled Inner Sheath: Model No. WA22017T
  • Breakage risk of ceramic tip
  • Immediate stop-use notice issued

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. WA22017T
UDI: 04042761051521
All Lots.
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

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