Stryker Recalls XCEL Bladeless Trocars Due to Cracking Risk
Stryker is recalling 9,072 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. The hazard involves a device component cracking or separating during use, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Stryker Sustainability Solutions is recalling 9,072 units of the XCEL Bladeless Trocar with Stability Sleeve 5x75mm. The product is manufactured by Ethicon Endo-Surgery, Inc. 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 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:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 9,072
Distribution
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