FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: 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-645L
- Recall number
- Z-1548-2024
- Recalling firm
- Olympus Corporation of the Americas
- Product
- 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-645L
- Status
- Open, Classified
- Initiated
- 2024-03-01
- Posted
- 2024-09-12
- Terminated
- not on file
- Reason
- 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
- Root cause
- Use error
- Action
- 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 Cynthia.Ow@Olympus.com.
- Quantity
- 2525 units
- Distribution
- Nationwide
- Lot, serial or model codes
- UDI-DI: - 04953170407857 All lots numbers
- 510(k) numbers
- ["K182408"]
- PMA numbers
- not on file
- Product code
- KNS
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28