Ethicon 5mm Endopath Xcel Trocar Recalled for Insufficient Lubrication
Ethicon Endo-Surgery is recalling 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or introduce minute particles.
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 source describes a 'remote chance' of harm without reported injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 14,873 units of the 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve (75mm shaft length, model 2B5ST). The recall covers lots P4T745, P4T88Y, P4T906, P4T91H, P4TA60, P4TC8M, P4TD0G, P4TD2K, R40015, R4011E, R4025E, R4035E, R4042Z, R4047X, and R4065E.
The recall was initiated because the product may have insufficient lubrication. This condition may prolong surgery due to the need for trocar replacement. Additionally, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
The affected products were distributed nationwide in the United States, including Puerto Rico, and internationally to Saudi Arabia, the United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina. Healthcare providers should stop using the affected devices and contact Ethicon Endo-Surgery for instructions on return or replacement.
The recalled product
- Product
- 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 14,873
Distribution
Part of a larger recall action
This product is one of 5 recalled by Ethicon Endo-Surgery Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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