Class II U.S. Food and Drug Administration

Stryker Sustainability Solutions REF:B11LT Ethicon Endo-Surgery recall: Reusable access port system may crack or seperate during use

Recall published last month

Reusable access port system may crack or seperate during use.

The hazard

Reusable access port system may crack or seperate during use.

Recall details

Recall number
Z-3184-2026
Published
September 23, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Stryker Sustainability Solutions
Product type
Medical devices
Units affected
25746 units
Distribution
Nationwide
Made in
United States
Lot / code info
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 16864262 16873298 16882066 16890447 16910583 16911077 16918348 16932643 16932670 16944854 16948846 16954589 16954752 16960057 16973101 16997240 17001744 17028440 17028570 17031601 17041299 17049923 17059628 17066538 17076463 17088783 17095646 17109581 17113435 17135548 17139463 17150688 17151102 17169646 17170177 17204941 17205450 17209368 17209375 17227100 17251065 17254141 17263845 17271186 17271210 17281823 17294417 17299147 17322114 17328034 17341513 17368858 17390430 17403535 17403664 17403934 17425110 17429906 17449215 17469249 17473233 17481923 17505258 17505372 17526291 17540762 17551599 17565554 17581089 17596921 17608897 17609204 17623498 17630896 17655989 17669388 17688040 17691616

Products covered by this recall

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

What this device recall means for you

Most device recalls are corrections rather than removals: the product stays in use and the manufacturer issues updated instructions, a software patch or a replacement part. Check which applies before you change anything.

  1. Match the model, catalogue and lot numbers above against the label on your device or its packaging.
  2. If the device is implanted or you depend on it daily, do not remove, disable or stop using it before speaking to your clinician. The notice above explains the specific failure mode they need to know about.
  3. If you are a clinician or facility, quarantine affected stock, check whether the manufacturer has issued a field correction, and work through your usual recall log.
  4. Home users should contact the supplier who provided the device — a hospital, DME company or online retailer — as they hold the serial-number records needed to action the recall.
  5. Problems with a device can be reported to the FDA through MedWatch, which feeds the same enforcement database this page is built from.

Replacements, repairs and reimbursement

Device remedies are handled through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number shown on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free of charge by the manufacturer, who pays return shipping.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not be charged a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim will rest on.

Company contact: Stryker Sustainability Solutions — 1810 W Drake Dr, Tempe, AZ, 85283-4327

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

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