Stryker Sustainability Solutions recalls Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE… and 5 other products
Stryker Sustainability Solutions recalled REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM and 5 other products beginning August 19, 2026, in a medical device recall whose distribution included Ohio. FDA assigned 6 recall numbers to the action, one per product; all of them are listed with this filing. The stated reason: Reusable access port system may crack or seperate during use. FDA graded it Class II — use may cause temporary or medically reversible health consequences. Quantity affected: 2838 units. The recall is listed as ongoing.
Writing the report from the record…
The source filing
| Recall number | Z-3183-2026 |
|---|---|
| Recalls in this action | 6 |
| Recalling firm | Stryker Sustainability Solutions |
| Product | REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM |
| Reason for recall | Reusable access port system may crack or seperate during use. |
| Classification | Class II — use may cause temporary or medically reversible health consequences |
| Recall type | medical device |
| Quantity | 2838 units |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm initiated |
| Initiated | 20260819 |
| Reported | 20260923 |
| Distribution | US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, O |
| Firm location | Tempe, AZ, United States |
Published by U.S. Food and Drug Administration (openFDA). This is the agency's public filing as The Lantern received it, shown with its fields named in plain English.