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 involves a risk-of-harm product (cracking/separation during surgery) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Stryker Sustainability Solutions is recalling the XCEL Bladeless Trocar with Stability Sleeve 5x100mm (REF:B5LT). The recall involves 205,704 units distributed nationwide in the United States, as well as in Israel and Canada.
The FDA has classified this as a Class II recall because the reusable access port system may crack or separate during use. This defect presents a risk of harm to patients during surgical procedures.
Healthcare facilities and consumers should stop using the affected devices immediately. Stryker is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 205,704
Distribution
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