FDA Medical Device Recalls (openFDA)
Stryker Sustainability Solutions: 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 Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar.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.
- Recall number
- Z-2468-2015
- 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 Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar.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.
- Status
- Terminated
- Initiated
- 2015-07-10
- Posted
- 2015-08-27
- Terminated
- 2015-12-04
- Reason
- 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
- 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
- 90 devices
- Distribution
- U.S. Nationwide Distribution to the following states of:: NV, NM, TX, and MI.
- Lot, serial or model codes
- Lot number 3574704 UDI Code: (01)00885825014421(17)180310(10)3574704 Model Number: CB5ST (labeled as CB5LT)
- 510(k) numbers
- ["K100080"]
- PMA numbers
- not on file
- Product code
- NLM
- Firm FEI
- 3009350690
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28