CLASS II ONGOING Device recall · Reported 11 Feb 2026 · FDA Enforcement Report
Olympus Single Use Electrosurgical Knife KD recalled
Olympus Corporation of the Americas is recalling Olympus Single Use Electrosurgical Knife KD-645, distributed nationwide in the US. The recall was initiated on 17 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1223-2026
- FDA event ID
- 98007
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Feb 2024
- FDA classified
- 30 Jan 2026
- Reported
- 11 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 17 Feb 2024 | Recall initiated by company | |
| 30 Jan 2026 | Classified by FDA | +713 days |
| 11 Feb 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98007This product is part of a recall event; the main page for the event is Olympus Single Use Electrosurgical Knife KD recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Olympus Single Use Electrosurgical Knife KD recalled | Olympus Corporation of the Americas | Device Malfunction | Nationwide |
More recalls from Olympus Corporation of the Americas
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|---|---|---|---|---|---|
| Device | CLASS II | Olympus M3 Gold Autoclavable Lateral Telescope recalled | Olympus Corporation of the Americas | Sterility | PA |
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| Device | CLASS II | Olympus M3 Gold Autoclavable Foroblique Telescope recalled | Olympus Corporation of the Americas | Sterility | PA |
| Device | CLASS II | Olympus BiCOAG Hemostasis Probe Fixed Pin Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
| Device | CLASS II | Olympus BiCOAG Hemostasis Probe Coaxial Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
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| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
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