CLASS II Device recall · Reported 2 Sep 2015 · FDA Enforcement Report

CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve recalled

Stryker Sustainability Solutions is recalling Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve, distributed nationwide in the US. The recall was initiated on 10 Jul 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number 3574704 UDI Code: (01)00885825014421(17)180310(10)3574704 Model Number: CB5ST (labeled as CB5LT)

Quantity recalled90 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2468-2015
FDA event ID: 71805
Recalling firm: Stryker Sustainability Solutions, Tempe, AZ
Classification: Class II
Status: Terminated
Recall initiated: 10 Jul 2015
FDA classified: 26 Aug 2015
Reported: 2 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Surgical Instruments

Timeline

10 Jul 2015	Recall initiated by company
26 Aug 2015	Classified by FDA	+47 days
2 Sep 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST).

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.

Where it was distributed

U.S. Nationwide Distribution to the following states of:: NV, NM, TX, and MI.

Nationwide Michigan New Mexico Nevada Texas

Questions about this recall

Is CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve Reprocessed by recalled?

Yes. Stryker Sustainability Solutions recalled CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve Reprocessed by on 10 Jul 2015. The recall is Class II and its status is Terminated. Recall number Z-2468-2015.

Why was it recalled?

Which lots are affected?

Lot number 3574704 UDI Code: (01)00885825014421(17)180310(10)3574704 Model Number: CB5ST (labeled as CB5LT)

Where was it sold?

U.S. Nationwide Distribution to the following states of:: NV, NM, TX, and MI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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