Reported May 23, 2018 · Terminated

5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT

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
    • 100mm shaft length
    • 2B5LT
Lot codes and dates
  • Lots
    • P4T58Y
    • P4T59E
    • P4T627
    • P4T665
    • P4T66C
    • P4T716
    • P4T71L
    • P4T780
    • P4T83K
    • P4T844
    • P4T87R
    • P4T88E
    • P4T88G
    • P4T88H
    • P4T927
    • P4T942
    • P4T946
    • P4T94D
    • P4TA19
    • P4TA3V
    • P4TA4N
    • P4TA4R
    • P4TA9K
    • P4TA9R
    • P4TC2E
    • P4TC2T
    • P4TC67
    • P4TC6Z
    • P4TD1M
    • R4000W
    • R40045
    • R4004G
    • R4007H
    • R4013R
    • R40172
    • R4017C
    • R4021R
    • R4021U
    • R4023D
    • R40267
    • R4026E
    • R4031V
    • R4036K
    • R4036V
    • R40397
    • R4041C
    • R4041J
    • R4044A
    • R4044K
    • R4048E
Amount recalled
118352

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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Ethicon Endo-Surgery Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 5:22 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.