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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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
- Bipolar Cutting Forceps
- Model numbers
- Model: 3005, UDI: 00821925035881, Lot Number: All unexpired
- Sizes
- 5 mm jaw, 33 cm length
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 25, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Verify device is Model 3005
- 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.
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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
- Worldwide distribution including US nationwide
- All unexpired lots affected
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Safety Guide
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