Quick Facts at a Glance
- Recall Date
- February 17, 2024
- 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
- Electrosurgical Knife
- Model numbers
- Model/Catalog Number: KD640-L UDI: 04953170208423 Lot Number(s): 2ZK, 31K, 32K, 33K, 34K, 35K, 36K, 37K +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 17, 2024
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during 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 Olympus Single Use Electrosurgical Knife KD-640L is used in surgeries to cut and coagulate tissues. This device is particularly essential in endoscopic procedures for precision and efficiency.
Why This Is Dangerous
The electrosurgical knife may overheat during use, leading to potential burns and tip breakage. This can compromise surgical safety and effectiveness.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face risks during surgeries if the device is not recalled. Immediate action is necessary to prevent potential injuries.
Practical Guidance
How to identify if yours is affected
- Verify the model number: KD640-L.
- Check lot numbers against the affected range: 2ZK to 47K.
- Inspect the device for any signs of damage or overheating.
Where to find product info
Serial numbers and lot numbers can typically be found on the packaging or device itself.
What timeline to expect
Expect a refund or replacement processing time of 4-8 weeks.
If the manufacturer is unresponsive
- Keep a record of all communication attempts.
- Consider escalating your inquiry to the FDA.
- Seek legal advice if necessary.
How to prevent similar issues
- Look for safety certifications when purchasing medical devices.
- Consider reviews and incident reports of similar products.
- Always ensure proper usage as per the manufacturer's guidelines.
Documentation advice
Document all communications regarding the recall, including emails and phone calls. Keep receipts and any product packaging.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The Olympus Single Use Electrosurgical Knife KD-640L is designed for cutting and coagulating tissues during surgeries. The affected model numbers include KD640-L and UDI 04953170208423, with lot numbers ranging from 2ZK to 47K. The device is distributed nationwide in the U.S.
Key Facts
- Recall date: February 17, 2024
- Model: KD640-L
- Risk of overheating and tip breakage
- Contact manufacturer for further instructions
- Distributed across the U.S.
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.