Z-1223-2026Class II

Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife...

Name: Z-1223-2026 Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife...
Creator: Olympus Corporation of the Americas
Published: 2024-02-17
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-02-17 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product... on 2024-02-17. FDA classified it as Class II and gives the reason as "A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1223-2026
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-17
Posted: 2026-01-30
Recalling firm: OLYMPUS Corporation of the Americas
Product: Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Root cause tag: design
FDA root cause: Device Design
Action: On December 17, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Carefully read the content of this notification. 2. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, including the instruction for intermittent output activation and applicable Warnings and Cautions. 3. Keep a copy of this notification with the Instructions for Use for any affected devices remaining in your inventory. 4. If you have further distributed the affected product, please identify your customers and forward this notification to them. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail [email protected].
Quantity in commerce: 3361 units
Distribution: US Nationwide distribution.
Product codes and lots: Model/Catalog Number: KD-645L UDI: 04953170407857 Lot Number(s): 2ZK, 31K, 32K, 33K, 35K, 3XK, 3YK, 3ZK, 42K, 43K, 44K, 45K, 46K, 47K, 48K, 49K, 4XK, 4YK, 4ZK, 51K, 52K, 53K, 54K, 55K, 56K, 57K, 58K, 59K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1223-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1222-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-01-30
Z-1223-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-01-30

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)