FDA Device recall Z-3185-2026
REF:B12LT Ethicon Endo-Surgery, Inc
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of REF:B12LT Ethicon Endo-Surgery, Inc by Stryker Sustainability Solutions, citing reusable access port system may crack or seperate during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3185-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-19 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Stryker Sustainability Solutions |
| Distribution | US |
Product
REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
Reason
Reusable access port system may crack or seperate during use.
Identifiers
| code_info | UDI: (01)00885825020897/ Lots: 16029001 16032878 16038822 16041414 16044000 16048542 16052751 16054119 16062169…UDI: (01)00885825020897/ Lots: 16029001 16032878 16038822 16041414 16044000 16048542 16052751 16054119 16062169 16062738 16066292 16074632 16087947 16087952 16090650 16098040 16107246 16111434 16115899 16115909 16120868 16130680 16130701 16135456 16136279 16138395 16140432 16140568 16142544 16142619 16159304 16160563 16172080 16176548 16186738 16186874 16187194 16187248 16187457 16197336 16201786 16205783 16205810 16205823 16206753 16220653 16220918 16221448 16221453 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Stryker Sustainability Solutions
- REF:2B5LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions - REF:B11LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions - REF:B5LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions - REF:B5ST Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions - REF:2B5ST Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions
All Stryker Sustainability Solutions recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3185-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.