Stryker Recalls Reprocessed Xcel Bladeless Trocars Due to Distribution Error
Stryker Sustainability Solutions is recalling 4,848 reprocessed Xcel Bladeless Trocars (H12LP) because they were distributed to facilities after a previous recall was executed.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a distribution error involving devices already subject to a previous recall, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Sustainability Solutions is recalling 4,848 units of the Reprocessed Xcel Bladeless Trocar (H12LP), Model # H12LP. These medical devices are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures. The affected units were distributed to facilities in the United States, specifically in the states of Oklahoma, Georgia, New Jersey, Texas, Iowa, Colorado, California, Louisiana, Pennsylvania, Virginia, Maryland, Washington, and Illinois.
The recall was initiated after an investigation determined that the H12LP Trocars, which were already in the scope of a previous recall, were distributed to facilities within the distribution chain following the initial recall execution activities performed by the distributor. This distribution error resulted in the devices reaching facilities after the recall process had already begun.
Facilities that have received these devices should stop using them and contact Stryker Sustainability Solutions for instructions on how to return or dispose of the product. Consumers should not use these devices if they have them in their possession.
The recalled product
- Product
- Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The…
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 4,848
Distribution
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