Single Use Electrosurgical Knife recallZ-1547-2024 · Olympus Corporation of the Americas · initiated Mar 1, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury
FDA root cause category: Use error
What the company is doing
Olympus Corporation of the Americas issued Medical Device Safety Reminder letter on 3/1/24 via UPS. Letter states reason for recall, health risk and action to take: 1. Follow your facility's procedures for communication and handling of Field Safety Notices. Ensure all personnel, including clinical staff, are informed of the contents of this letter and the Instructions for Use. You may add a copy of this letter with your IFU. 2. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall. b. Enter the recall number: 0443 c. Complete the form as instructed. 3. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. Olympus requests you to report any complaints, including any injuries associated with Triangle Tip Electrosurgical knife tip breakage, the Olympus Technical Assistance Center at 1-800-848-9024, option 1. If you require additional information, please do not hesitate to contact me directly at 647-999-3203 or [email protected].
Recall details
- Recall number
- Z-1547-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 1, 2024
- Posted by the FDA
- Sep 12, 2024
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 4507 units
- Product code
- KNS
- FDA submissions
- K182408
- Distribution
- Nationwide
Product description
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640L
Code information (models, lots, serial numbers)
UDI-DI: 04953170208423 All lots numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Single Use Electrosurgical Knife KD-640LOlympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)2 recalls19 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 94173).
- Z-1548-2024 · Open, ClassifiedOlympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive trac…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page