The Recall Desk
HighFDA (Devices)·Z-3184-2026·Announced 2026-09-23

Stryker Recalls XCEL Bladeless Trocars 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 is classified as FDA Class II, and the hazard involves a medical device that may crack or separate during use, posing a risk of harm where injury has not yet been reported.

Plain-English summary

Stryker Sustainability Solutions is recalling 25,746 units of the XCEL Bladeless Trocar with Stability Sleeve (11x100mm). 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. The recall covers specific lot numbers listed in the agency's official documentation.

Healthcare providers and consumers should stop using the affected devices immediately. Users should contact Stryker Sustainability Solutions for instructions on how to return the devices or obtain a replacement.

The recalled product

Product
REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM
Manufacturer
Stryker Sustainability Solutions
Category
Medical Device — Surgical Instruments
Hazard
Affected units
25,746

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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