Olympus Recalls Single Use Electrosurgical Knife KD-645 Over Tip Breakage Concerns
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Olympus Corporation of the Americas is recalling over 3,300 electrosurgical knives due to risks of overheating and tip breakage during endoscopic surgery.
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 "high" 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, MedicalDevice.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of the Single Use Electrosurgical Knife KD-645. The recall was prompted by reports of deterioration of the cutting knife, including instances of overheating and burning. These conditions can contribute to the tip of the device breaking while in use during surgical procedures.
Which Products Are Affected
The recall involves 3,361 units of the following medical device:
- Brand Name: Single Use Electrosurgical Knife KD-645
- Model/Catalog Number: KD-645L
- UDI: 04953170407857
- Lot Numbers: 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
These devices are intended for use in endoscopic surgeries (including laparoscopic and arthroscopic) to deliver current for tissue cutting, coagulation, or ablation.
What You Should Do
The firm initiated the recall through a notification letter sent to affected customers. Healthcare providers and facilities should immediately check their inventory for the specified lot numbers. Affected units should be quarantined and handled according to the instructions provided by Olympus. For additional information regarding the return process, 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. Tip breakage during surgery poses a serious risk, as it may require additional procedures to retrieve the broken component or cause unintended tissue damage.
Source
Recall information provided by the FDA under Recall Number Z-1223-2026.
Original source: FDA Official Notice ↗
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