Class II U.S. Food and Drug Administration

Stryker Sustainability Solutions REF:B5ST 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-3187-2026
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
9072 UNITS
Distribution
Nationwide
Made in
United States
Lot / code info
UDI:(01)00885825014254/ Lots: 16028740 16083100 16098933 16106547 16130667 16160384 16160418 16160460 16181332 16201793 16207031 16234052 16264116 16418941 16421915 16422882 16476685 16493231 16948345 16954673 16977948 16993151 17151380 17160201 17210355 17239624 17271015 17271027 17324927 17341521 17342144 17378894 17412852 17426084 17457260 17491569 17499741 17512459 17521310 17526338

Products covered by this recall

REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM

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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