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 is classified as FDA Class II, and the hazard involves a device defect (cracking/separation) that poses a risk of harm during surgical use, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Stryker Sustainability Solutions is recalling the XCEL Bladeless Trocar with OptiView Technology & Sleeve (5mm x 100mm). The recall is due to a defect where the reusable access port system may crack or separate during use.
The affected units 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 involves 7,5966 units across numerous specific lot numbers.
Healthcare providers and consumers should stop using the affected devices immediately and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 75,966
Distribution
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