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Olympus Resection Sheath Recalled Due to Ceramic Tip Breaking

Olympus Corporation of the Americas recalled 1,634 units of the A22042T Resection Sheath on November 11, 2025. The recall follows complaints of the ceramic tip breaking, posing a high risk to patients. Healthcare providers and patients must stop using the device immediately.

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
Resection Sheath
Model numbers
Model No. A22042T, UDI: 04042761020992, 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 Resection Sheath is used in urologic procedures to assist in surgical interventions. It is typically employed in procedures requiring tissue resection.

Why This Is Dangerous

The ceramic tip may break during use, which can lead to potential injuries during surgery. This defect raises concerns about patient safety in medical environments.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers must stop using the device, which could disrupt planned medical procedures and necessitate alternative solutions.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the device to confirm if it is A22042T.
  2. Look for the UDI code 04042761020992 on the packaging or the device.
  3. Verify the recall notice and match your purchase date against the recall timeline.

Where to find product info

The model number and UDI code are typically found on the product packaging or the device itself, usually near the base or handle.

What timeline to expect

Expect the recall resolution process to take approximately 4-6 weeks for refunds or replacements.

If the manufacturer is unresponsive

  • Contact Olympus customer service again for follow-up.
  • Document your communications and consider filing a complaint with regulatory bodies.

How to prevent similar issues

  • Consider safety certifications when purchasing medical devices.
  • Research product reviews and safety records before use.
  • Consult healthcare professionals about device alternatives.

Documentation advice

Keep all receipts, warranty information, and communications regarding the recall for future reference.

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Product Details

The recalled product is the Olympus Resection Sheath, model number A22042T, with UDI 04042761020992. It was distributed nationwide across the United States.

Key Facts

  • Model No. A22042T
  • Distribution: US Nationwide
  • 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 Classification

Product Details

Model Numbers
Model No. A22042T
UDI: 04042761020992
All Lots.
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

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