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Z-2468-2015 Class II Terminated

Recalled by Stryker Sustainability Solutions — Tempe, AZ

FDA device recall Z-2468-2015 was initiated by Stryker Sustainability Solutions on Jul 10, 2015 and is designated Class II. 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… The recall status is terminated (terminated Dec 4, 2015). Affected quantity: 90 devices.

Recall Details

Product Type: Devices
Report Date: Sep 2, 2015
Initiation Date: Jul 10, 2015
Termination Date: Dec 4, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 90 devices

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 Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar.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

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).

Distribution Pattern

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

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2468-2015
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.