Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1223-2026 — 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

U.S. FDA — Device Enforcement · United States · 2024-02-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1223-2026
Date of alert: 2024-02-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Olympus Corporation of the Americas
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 04953170407857

Reported risk: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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