Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery — Class II medical device recall Z-2468-2015
Terminated recall by Stryker Sustainability Solutions, reported 2015-09-02, distributed nationwide. Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were
| Recall number | Z-2468-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2015-07-10 |
| Classified | 2015-08-26 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2015-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 90 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00885825014421 |
| Lot numbers | 3574704 |
| Model numbers | CB5ST |
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 Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar.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.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2468-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.