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
- 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
- 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: 3006, UDI: 00821925035898, Lot Numbers: All unexpired
- Sizes
- 5 mm jaw, 33 cm length
- Sold at
- Multiple Retailers
- 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 passed through a 5 mm cannula and used to coagulate tissue with electrosurgical energy under visualization. The device is intended for use with compatible bipolar generators.
Why This Is Dangerous
A welding-process validation issue can lead to defective welds. The jaw may break during clinical use, potentially injuring the patient or compromising the procedure.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt procedures using this device. A jaw breakage could require device replacement mid-procedure and impose costs on facilities.
Practical Guidance
How to identify if yours is affected
- Confirm device model 3006
- Verify lot numbers are unexpired
- If affected, stop using immediately
- Follow Olympus recall instructions
Where to find product info
Recall notices and instructions are available on the FDA enforcement page linked to recall Z-1639-2026 and through Olympus communications.
What timeline to expect
The recall notice does not specify a replacement or refund timeline.
If the manufacturer is unresponsive
- Escalate to FDA recall contact channels
- Consult hospital risk management if the manufacturer is unresponsive
How to prevent similar issues
- Verify UDI and model before procurement
- Maintain an active recall monitoring process for surgical instruments
- Require suppliers to provide recall communications promptly
Documentation advice
Keep the recall notice, device serials/UDIs, exchange communications, and records of returns or replacements.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model: 3006; UDI: 00821925035898; Lot Numbers: All unexpired; Sold worldwide (US, Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan); Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 164 units recalled worldwide
- Lot numbers: All unexpired
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.