Ethicon recalls specific 5mm Endopath Xcel trocars with Optiview Technology due to potential surgery prolongation and rare particle risk from insufficient lubrication during use.
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, 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.
Ethicon is recalling certain 5mm Endopath Xcel trocars with Optiview Technology because using them without enough lubrication might extend surgery time and rarely cause tiny particles to enter the body. This recall affects surgeons and medical staff who use these devices during procedures.
Insufficient lubrication during surgery could cause the trocar to need replacement, prolonging the procedure. Repeated insertions might damage the seal, creating a very small chance of tiny particles entering the body.
Surgeons and medical staff using the recalled trocars during procedures are most at risk. The recall applies to specific model numbers and production lots sold between 2020 and 2:00 PM EST on May 1, 2020.
Check for the model name '5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST' and production lots listed in the recall notice.
Compare your product's lot number to the list of affected lots: P4T745, P4T88Y, P4T906, P4T91H, P4TA60, P4TC8M, P4TD0G, P4TD2K, R40015, R4011E, R4025E, R4035E, R4042Z, R4047X, R4065E.
Insufficient lubrication during surgery may prolong the procedure and rarely introduce tiny particles into the body if the trocar seal is damaged.
Check your product's lot number against the list of affected lots provided in the recall notice.
The recall states a 'remote chance' of particles entering the body, which is considered low risk. Serious injury is not mentioned in the hazard description.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1886-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1886-2018 from Ethicon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
