HIGH

Olympus Everest Bipolar Cutting Forceps 3005 Recalled for Jaw Break Risk in 2026

Olympus Corporation of the Americas is recalling 106 Everest Bipolar Cutting Forceps worldwide. The devices can have welding defects that may cause the jaw to break during use. Stop using immediately and contact Olympus or your healthcare provider for instructions.

Quick Facts at a Glance

Recall Date
February 25, 2026
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

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

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 Everest Bipolar Cutting Forceps are surgical instruments passed through a 5 mm cannula to coagulate tissue with bipolar energy. They are designed for use with compatible generators.

Why This Is Dangerous

A welding validation issue may lead to jaw fracture during use, risking patient safety during procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals and clinics may need to halt procedures using affected devices and seek replacements or alternatives to maintain workflow and patient safety.

Practical Guidance

How to identify if yours is affected

  1. Verify device is Model 3005
  2. Check UDI 00821925035881
  3. Check all lot numbers for unexpired status

Where to find product info

Labels on the deviceInclude model, UDI, and lot numbers.

What timeline to expect

Remedies typically require coordination with Olympus; timelines vary by facility and geography.

If the manufacturer is unresponsive

  • Document outreach attempts and dates
  • Escalate to hospital compliance or recall hotlines
  • Consult FDA/CP SC for guidance if no response

How to prevent similar issues

  • Verify UDI and model numbers before use
  • Routinely audit supplier welding validation
  • Maintain an instrument recall log

Documentation advice

Keep the recall notice, device labels, UDI, lot numbers, and all correspondence for records.

Product Details

Model 3005. UDI 00821925035881. All unexpired lots are affected. Distributed worldwide, including US nationwide, Canada, Mexico, EU, Australia, China, Singapore, Korea, and Japan. Recall date: 2026-02-25. Status: ACTIVE.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 106 units recalled
  • Worldwide distribution including US nationwide
  • Model 3005, UDI 00821925035881
  • All unexpired lots affected
  • Recall date 2026-02-25

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
LACERATION

Product Details

Model Numbers
Model: 3005
UDI: 00821925035881
Lot Number: All unexpired
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

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