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: KD-645L UDI: 04953170407857 Lot Number(s): 2ZK, 31K, 32K, 33K, 35K, 3XK, 3YK, 3ZK +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-645L is designed for cutting and coagulating tissue during surgical procedures. Surgeons often use this device in endoscopic surgeries, including laparoscopic operations.
Why This Is Dangerous
The knife's cutting mechanism may overheat, leading to deterioration and burning. This can result in tip breakage, posing burn risks during surgical use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects surgical procedures where the electrosurgical knife is used, potentially delaying medical interventions and posing serious safety risks.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device.
- Verify the lot numbers against those listed in the recall notice.
- Look for any signs of damage or overheating.
Where to find product info
Model numbers and lot numbers can usually be found on the packaging or the device itself.
What timeline to expect
Expect 4-6 weeks for the refund process after returning the product.
If the manufacturer is unresponsive
- Contact Olympus customer service directly for assistance.
- Document your attempts to communicate with the company.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Look for safety certifications and recent safety reports.
- Consult with healthcare providers about device safety.
Documentation advice
Keep a record of any correspondence with the manufacturer and take photos of the product if necessary.
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Product Details
The recalled product is the Olympus Single Use Electrosurgical Knife, model KD-645L. It consists of a handpiece and monopolar electrode designed for surgical procedures. The product was distributed across the United States.
Key Facts
- Recall date: February 17, 2024
- Model number: KD-645L
- Potential burn and tip breakage risks
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Safety Guide
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