Stryker Sustainability Solutions: Medical Device Recall in 2015 - (Recall #: Z-2468-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar.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.

Product Classification:

Class II

Date Initiated: July 10, 2015

Date Posted: September 2, 2015

Recall Number: Z-2468-2015

Event ID: 71805

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).

Status: Terminated

Product Quantity: 90 devices

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated