Ethicon Endo-Surgery Recalls 5mm Endopath Xcel Trocars Due to Lubrication Issues
Ethicon Endo-Surgery is recalling 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or risk introducing minute particles.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a remote chance of introducing a minute particle and prolonging surgery, which fits the criteria for moderate risk without reported serious injuries or deaths.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 118,352 units of the 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve. The affected lots were distributed nationwide in the United States, including Puerto Rico, and internationally to Saudi Arabia, the United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
The recall was initiated because the product may have insufficient lubrication. This issue could prolong surgery due to the need for trocar replacement. Additionally, insufficient lubrication creates a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Healthcare providers and facilities should stop using the affected lots and contact Ethicon Endo-Surgery for instructions on return or replacement.
The recalled product
- Product
- 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 118,352
Distribution
Part of a larger recall action
This product is one of 5 recalled by Ethicon Endo-Surgery Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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