Stryker Recalls Reprocessed Xcel Bladeless Trocars Due to Plug Breakage
Stryker is recalling 40,476 reprocessed Xcel Bladeless Trocars because the adjustable plug may break in packaging or 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 component breaking during use in a surgical setting, which poses a risk of harm even though specific injuries are not detailed in the source text.
Plain-English summary
Stryker Sustainability Solutions is recalling 40,476 units of the Reprocessed Xcel Bladeless Trocar (Model # H12LP). These devices are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
The recall is being conducted due to an increase in reports indicating that the trocar's adjustable plug may break in the packaging or during use. The affected devices were distributed worldwide, including nationwide in the United States and internationally to Israel and Canada.
Healthcare providers and facilities should stop using the affected devices and contact Stryker Sustainability Solutions for instructions on how to return or dispose of them. Patients who have had these devices used in their surgeries should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 40,476
Distribution
Distributed nationwide across the United States.
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