Ethicon 5mm Endopath Xcel Trocar Recalled for Lubrication Defect
Ethicon Endo-Surgery Inc is recalling 5mm Endopath Xcel trocars due to insufficient lubrication, which 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, without reports of hospitalization or significant injury, fitting the Moderate criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling the 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT. The recall involves 95,233 units 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 is due to insufficient lubrication in the product. 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 should stop using the affected lots and contact Ethicon Endo-Surgery Inc for instructions on return or replacement. The affected lot numbers are P4T636, P4T63G, P4T689, P4T708, P4T86Z, P4T882, P4T89N, P4T97L, P4T994, P4TA0T, P4TA17, P4TA55, P4TA70, P4TA7R, P4TC53, P4TC7X, P4TC87, P4TC8U, P4TC93, P4TD1Y, R4003L, R40048, R4005Z, R4010L, R4012F, R40142, R4020P, R4021H, R4027N, R4042X, R4045N, R4046X, and R4054H.
The recalled product
- Product
- 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 95,233
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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