Z-2468-2015Class II

Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm...

Name: Z-2468-2015 Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm...
Creator: Stryker Sustainability Solutions
Published: 2015-07-10
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2015-07-10 / Terminated / root cause: labeling and UDI

FDA source

Stryker Sustainability Solutions began a recall of Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability... on 2015-07-10. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2468-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-10
Posted: 2015-08-27
Terminated: 2015-12-04
Recalling firm: Stryker Sustainability Solutions
Product: 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 Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar.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 code: NLM Laparoscope, General & Plastic Surgery, Reprocessed
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).
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 07/10/15 the firm sent out notification letters to all customers. The letter states for the customer to discontinue use of the affected lot, and to use other trocar lots reporcessed by the firm. The firm requests that the Recall Effectiveness Check Form be completed. The firm is going to be sending a sales representative to the facilities to check inventory for the affected trocars. A Recall Effectiveness Check will also be completed. If the form indicates that affected devices remain in inventory a prepaid shipping label will be issued for the return of the product. Customers will receive credit for all affected devices returned. The form must be completed even if no affected devices are found in inventory. Stryker Sustainability Solutions Complaint Hotline: 1-888-888-3433 x5555
Quantity in commerce: 90 devices
Distribution: U.S. Nationwide Distribution to the following states of:: NV, NM, TX, and MI.
Product codes and lots: Lot number 3574704 UDI Code: (01)00885825014421(17)180310(10)3574704 Model Number: CB5ST (labeled as CB5LT)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2468-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2468-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-26

Product code NLM

K100080Class IIReprocessed Trocars, Model B5lt and Cb5ltAscent Healthcare Solutions / cleared 2010-03-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)