Olympus Recalls Single Use Electrosurgical Knife KD-640L Due to Tip Breakage Risk
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Olympus Corporation of the Americas has issued a voluntary recall for its KD-640L electrosurgical knife due to risks of overheating and tip breakage during surgical procedures.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of the Olympus Single Use Electrosurgical Knife KD-640L. The recall was prompted by reports of deterioration of the cutting knife, which can include overheating and burning. These conditions can contribute to the knife tip breaking during medical procedures.
Which Products Are Affected
The recall involves the following medical device:
- Product Name: Olympus Single Use Electrosurgical Knife KD-640L
- Model/Catalog Number: KD640-L
- UDI: 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
This product is an electrosurgical device intended for cutting, coagulation, and ablation during endoscopic surgeries. The affected units were distributed nationwide across the United States.
What You Should Do
Olympus Corporation of the Americas notified affected customers via letter. Healthcare facilities and providers should immediately check their inventory for the specified model and lot numbers. Affected units should be quarantined to prevent use. For further information regarding returns or technical questions, contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034.
Why This Matters
This is a Class II recall, indicating that the use of the defective device may cause temporary or medically reversible adverse health consequences. The primary risk involves the potential for device fragments to break off inside a patient during surgery due to overheating or deterioration.
Source
Information provided by the FDA under Recall Number Z-1222-2026.
Original source: FDA Official Notice ↗
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