Brand Name: Single Use Electrosurgical Knife Product Name: Olympus… — Class II medical device recall Z-1222-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-02-11, distributed nationwide. A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during
| Recall number | Z-1222-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2024-02-17 |
| Classified | 2026-01-30 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04953170208423 |
| Lot numbers | 2ZK, 31K, 32K, 33K, 34K, 35K, 36K, 37K, 38K, 39K, 3XK, 3YK, 3ZK, 41K, 42K, 43K, 44K, 45K, 46K, 47K, 48K, 49K, 4XK, 4YK, 4ZK, 51K, 52K, 53K, 54K, 55K, 58K, 59K |
| Model numbers | KD640-L |
Product
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1222-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.