Z-1223-2026 Class II Ongoing
FDA device recall Z-1223-2026 was initiated by Olympus Corporation Of The Americas on Feb 17, 2024 and is designated Class II. Reason for recall: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use. The recall status is ongoing. Affected quantity: 3361 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 11, 2026
- Initiation Date
- Feb 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3361 units
Product Description
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.
Reason for Recall
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Distribution Pattern
US Nationwide distribution.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1223-2026
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026