Stryker recalls mislabeled 5mm trocar sleeves due to length discrepancy
Stryker Sustainability Solutions is recalling 90 reprocessed trocar sleeves labeled as 100mm but containing 75mm models.
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, and the hazard is a labeling error (length discrepancy) without reported injuries or illnesses, fitting the Moderate criteria for minor labeling errors or low-risk issues.
Plain-English summary
Stryker Sustainability Solutions is recalling 90 units of reprocessed Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve, 5mm x 100mm. The recall involves lot number 3574704, which was distributed nationwide to Nevada, New Mexico, Texas, and Michigan.
The recall was initiated after reports indicated that devices from this specific lot were labeled as 100mm models (CB5LT), but the devices inside the packaging were actually 75mm models (CB5ST). This labeling discrepancy creates a risk that healthcare providers may use a device of a different length than intended for a surgical procedure.
Healthcare facilities should stop using the affected devices and contact Stryker Sustainability Solutions for instructions on how to return them. The affected devices are sterile single-patient use devices used to minimize gas leakage during laparoscopic procedures.
The recalled product
- Product
- Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile…
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 90
Distribution
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