Z-1548-2024Class II

Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to...

Name: Z-1548-2024 Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to...
Creator: Olympus Corporation of the Americas
Published: 2024-03-01
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-03-01 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the... on 2024-03-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1548-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-01
Posted: 2024-09-12
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
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: 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 tag: labeling and UDI
FDA 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 [email protected].
Quantity in commerce: 2525 units
Distribution: Nationwide
Product codes and lots: UDI-DI: - 04953170407857 All lots numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1548-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1547-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-04-16
Z-1548-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-04-16

Product code KNS

K182408Class IISingle Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645Olympus Medical Systems Corp. / cleared 2019-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)