Agency classClass IIOur severity:High FDA (Devices)·Z-1889-2018·Announced 2018-05-23

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a defect (insufficient lubrication) poses a risk of harm (introduction of minute particles) and operational disruption (prolonged surgery), but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Ethicon Endo-Surgery Inc is recalling the 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve (75mm shaft length, model 2CB5ST). The recall involves 11,074 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 issued 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 should stop using the affected lots and contact Ethicon Endo-Surgery Inc for instructions on return or replacement. The affected lot numbers are P4T686, P4T79A, P4T99K, P4TC30, P4TD2D, R40191, R40223, R4045J, R4054D, and R40642.

The recalled product

Product: 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
Manufacturer: Ethicon Endo-Surgery Inc
Category: Medical Device — Surgical Instruments
Hazard: foreign-object-introduction
device-malfunction
Affected units: 11,074

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 5 products in this recall →

Same manufacturer · Ethicon Endo-Surgery Inc

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Same hazard · foreign object introduction