Reported May 23, 2018 · Terminated

5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST

Ethicon Endo-Surgery Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ethicon Endo-Surgery Inc · 4545 Creek Rd · Blue Ash, OH · 45242-2803

Is this the product you have?

    • 5mm Endopath Xcel with Optiview Technology
    • Bladeless Trocar with Stability Sleeve
    • 5mm
    • 75mm shaft length
    • 2B5ST
Lot codes and dates
  • Lots
    • P4T745
    • P4T88Y
    • P4T906
    • P4T91H
    • P4TA60
    • P4TC8M
    • P4TD0G
    • P4TD2K
    • R40015
    • R4011E
    • R4025E
    • R4035E
    • R4042Z
    • R4047X
    • R4065E
Amount recalled
14873

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 8, 2020 · Data as of Sep 19, 6:12 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.