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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 2,838
Distribution
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