Ethicon Endo-Surgery Recalls 5mm Endopath Xcel Trocars Due to Lubrication Defect
Ethicon Endo-Surgery is recalling 1,500 units of 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or introduce minute particles.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text describes the hazard as a 'remote chance' of introducing a minute particle and prolonging surgery, with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 1,500 units of the 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT. The affected lots are P4TD1E, R4001U, and R4052P. The product was 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 defect may prolong surgery due to the need for trocar replacement. Additionally, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Healthcare providers and facilities that have received these products should stop using them and contact Ethicon Endo-Surgery Inc for further instructions on the recall process.
The recalled product
- Product
- 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 1,500
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots P4TD1E R4001U R4052P
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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