The Recall Desk
HighFDA (Devices)·Z-3183-2026·Announced 2026-09-23

Stryker Recalls XCEL Bladeless Trocar Due to Cracking Risk

Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (cracking/separation) that poses a risk of harm during use, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Stryker Sustainability Solutions is recalling 2,838 units of the XCEL Bladeless Trocar with OptiView Technology & Sleeve 5mm x 75mm (REF:2B5ST). The recall is due to a defect where the reusable access port system may crack or separate during use.

The affected devices were distributed nationwide in the United States, including all 50 states, the District of Columbia, and Puerto Rico, as well as in Israel and Canada. Specific lot numbers are listed in the recall documentation.

Healthcare providers should stop using the affected devices and contact Stryker for instructions on how to return or replace them.

The recalled product

Product
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Manufacturer
Stryker Sustainability Solutions
Category
Medical Device — Surgical Instruments
Hazard
Affected units
2,838

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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