RecallRadar

FDA Device recall Z-3184-2026

REF:B11LT Ethicon Endo-Surgery, Inc

On 2026-09-23 the FDA classified a Class II recall of REF:B11LT 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

AgencyFDA Device
Recall numberZ-3184-2026
ClassificationClass II
Statusongoing
Initiated2026-08-19
Published2026-09-23
Last updated2026-09-29 05:30 UTC
CompanyStryker Sustainability Solutions
DistributionUS

Product

REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM

Reason

Reusable access port system may crack or seperate during use.

Identifiers

code_info
UDI: (01)00885825014278/ Lots: 16029055 16032602 16043960 16061865 16070321 16087746 16098637 16110046 16114368…UDI: (01)00885825014278/ Lots: 16029055 16032602 16043960 16061865 16070321 16087746 16098637 16110046 16114368 16130717 16135711 16143130 16146135 16151146 16160441 16168393 16176147 16181210 16193613 16193841 16197273 16210637 16225560 16234068 16243073 16255238 16270273 16281198 16288334 16294565 16297693 16298302 16330851 16331282 16343635 16347401 16371411 16371424 16388088 16403183 16403718 16414106 16427432 16431368 16447949 16467342 16477495 16487698 16494506 16500580 16508571 16521742 16532270 16535613 16535744 16548007 16555888 16570108 16574637 16587696 16587715 16590797 16599333 16599403 16604291 16608764 16623439 16633133 16645377 16651357 16652029 16655384 16665681 16674817 16675666 16705350 16705494 16713074 16716790 16721202 16729496 16745595 16746009 16759208 16763700 16774402 16778721 16793395 16796870 16806597 16813889 16818038 16826959 16830829 16841701 16845712 16850270 16854348

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

All Stryker Sustainability Solutions recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3184-2026%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.