Ethicon recalls 5mm Endopath Xcel trocars with Optiview Technology due to potential surgery delays 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 5mm Endopath Xcel trocars with Optiview Technology because using them without enough lubrication might cause surgery to last longer and could rarely introduce a tiny particle. This is a safety concern for surgical teams using the device.
Insufficient lubrication during surgery can cause the trocar to become stuck, requiring repeated insertion which might damage the device's seal. This could rarely introduce a tiny particle into the surgical site, though the risk is very low.
Surgical teams using the recalled trocars during procedures are most at risk. Patients undergoing surgery with this specific model may be affected if the trocar is used without proper lubrication.
Check for the model name '5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT'. The product was sold with lots P4TD1E, R4001U, and R4052P.
Ensure adequate lubrication is used during surgery to prevent prolonged procedure times and potential seal damage.
No, the recall is only for situations where insufficient lubrication is used during surgery.
It may cause surgery to last longer and could rarely introduce a tiny particle into the surgical site.
Look for the model name '5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT' and lots numbers P4TD1E, R4001U, or R4052P.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1887-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1887-2018 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.
