Recall Z-3184-2026 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
Stryker Sustainability Solutions
REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM
| Date | Sep 16, 2026 (initiated Aug 19, 2026) |
| Status | Open, Classified |
| Reason | Reusable access port system may crack or seperate during use. |
| Root cause | Device Design |
| Action | On August 19, 2026, Stryker Sustainability Solutions (SSS)issued a Urgent: Medical Device recall notice to affected consignees via sales representative and US Mail. SSS ask consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Immediately check your internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use. 3. Complete the Business Reply Form or use the QR Code on Attachment A. Response is required. a.If you have indicated that product remains in your inventory, |
| Quantity | 25746 units |
| 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, Mis |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201511 | Reprocessed Endoscopic Trocars and Sleeves Stryker Sustainability Solutions, Jul 31, 2020 |