Lower risk Medical device recall · FDA · Published March 26, 2018

Ethicon 5mm Endopath Xcel Recall: Insufficient Lubrication May Prolong Surgery

Ethicon recalls 5mm Endopath Xcel surgical devices with Optiview Technology due to potential surgery prolongation from insufficient lubrication. This recall affects specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1889-2018Medical device Ethicon ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmEthicon Endo-Surgery Inc4545 Creek Rd · Blue Ash, OH 45242-2803

✎ GovInfoNow plain-language explainer

Ethicon is recalling certain 5mm Endopath Xcel surgical devices that may cause surgery to last longer if not properly lubricated. There's also a small chance of a tiny particle entering the body during repeated use. Read more at govinfonow.com/recall/71611-ethicon-5mm-endopath-xcel-recall-insufficient-lubrication-may-prolong-surgery.

Source Summary by GovInfoNow · govinfonow.com/recall/71611-ethicon-5mm-endopath-xcel-recall-insufficient-lubrication-may-prolong-surgery · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1889-2018

Cite this page

“Ethicon 5mm Endopath Xcel Recall: Insufficient Lubrication May Prolong Surgery.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71611-ethicon-5mm-endopath-xcel-recall-insufficient-lubrication-may-prolong-surgery. Based on FDA recall #Z-1889-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1889-2018%22&limit=1).

Ethicon Endo-Surgery Inc recalled 5mm Endopath Xcel trocars on March 26, 2018, due to insufficient lubrication risks. The U.S. Food and Drug Administration announced the Class II recall.

How to tell if you have it

Brand: Ethicon
Product: 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
Lots: P4T686, P4T79A, P4T99K, P4TC30, P4TD2D, R40191, R40223, R4045J, R4054D, R40642

The hazard

Context

GovInfoNow's records show Ethicon Endo-Surgery Inc has 12 other recalls on record since October 23, 2017. Other recent recalls include Ethicon ECHELON LINEAR Cutters Reload 80mm Blue (September 11, 2025), Ethicon Endopath Echelon Vascular White Reload (April 22, 2025), and Ethicon Endo-Surgery ECHELON 45mm Staple Reloads (December 11, 2023). Other recent recalls of similar products include Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), Olymp Disposable Triple Lumen Sphincterotome (January 7, 2026), and Stryker XCEL Bladeless Trocar W/Stability Sleeve 5x75mm Recall (August 19, 2026).

How to tell if you have this one

Check for the model name '5mm Endopath Xcel with Optiview Technology' and the lot numbers listed: P4T686, P4T79A, P4T99K, P4TC30, P4TD2D, R40191, R40223, R4045J, R4054D, R40642.

Brand
Ethicon
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.

Recall number	Product, codes & lots	Quantity
Z-1885-2018	5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT; 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	118352
Z-1886-2018	5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST; Lots P4T745 P4T88Y P4T906 P4T91H P4TA60 P4TC8M P4TD0G P4TD2K R40015 R4011E R4025E R4035E R4042Z R4047X R4065E	14873
Z-1887-2018	5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT; Lots P4TD1E R4001U R4052P	1500
Z-1888-2018	5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT; Lots 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 R4054H	95233
Z-1889-2018	5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST; Lots P4T686 P4T79A P4T99K P4TC30 P4TD2D R40191 R40223 R4045J R4054D R40642	11074

Based on the official FDA remedy

What to do — step by step

Check Product Lot Numbers
Identify the lot numbers on your device to see if they match the recalled list: P4T686, P4T79A, P4T99K, P4TC30, P4TD2D, R40191, R40223, R4045J, R4054D, R40642.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

Mar 26, 2018Firm started the recall
May 15, 2018FDA classified it Class II
May 23, 2018Published in FDA’s Enforcement Report
Apr 8, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have the recalled device?

The recall does not require immediate action, but you should check the lot numbers to confirm if your device is affected.

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Link to this recall

<a href="https://govinfonow.com/recall/71611-ethicon-5mm-endopath-xcel-recall-insufficient-lubrication-may-prolong-surgery">Ethicon 5mm Endopath Xcel Recall: Insufficient Lubrication May Prolong Surgery (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1889-2018 (March 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1889-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.