The Recall Desk
HighFDA (Devices)·Z-3185-2026·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 is classified as FDA Class II, and the hazard involves a structural defect (cracking/separation) in a medical device used during surgery, which presents a risk of harm even without reported injuries.

Plain-English summary

Stryker Sustainability Solutions is recalling the Ethicon Endo-Surgery, Inc. XCEL Bladeless Trocar with Stability Sleeve (12x100mm). The recall involves 2,682 units of the device.

The recall was initiated because the reusable access port system may crack or separate during use. This defect poses a potential risk to patients and healthcare providers during surgical procedures.

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. Healthcare facilities and distributors should check their inventory for the specific lot numbers listed in the recall notice and stop using the affected devices immediately.

The recalled product

Product
REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
Manufacturer
Stryker Sustainability Solutions
Category
Medical Device — Surgical Instruments
Hazard
Affected units
2,682

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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