Ethicon recalls 5mm Endopath Xcel surgical devices with Optiview Technology due to potential surgery prolongation from insufficient lubrication. This recall affects specific lot numbers.
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 surgical devices that may cause surgery to last longer if not properly lubricated. There's also a small chance of a tiny particle entering the body during repeated use.
Insufficient lubrication can cause the trocar to need replacement during surgery, prolonging the procedure. Repeated insertions might damage the seal, potentially introducing a tiny particle into the body.
Surgical teams using the recalled devices during procedures. Patients undergoing surgery with these specific models are at risk if the device isn't lubricated properly.
Check for the model name '5mm Endopath Xcel with Optiview Technology' and the lot numbers listed: P4T686, P4T79A, P4T99K, P4TC30, P4TD2D, R40191, R40223, R4045J, R4054D, R40642.
Identify the lot numbers on your device to see if they match the recalled list: P4T686, P4T79A, P4T99K, P4TC30, P4TD2D, R40191, R40223, R4045J, R4054D, R40642.
Ethicon recalls these devices because insufficient lubrication may prolong surgery and there's a remote chance of a tiny particle entering the body during repeated use.
Check the lot numbers on your device: P4T686, P4T79A, P4T99K, P4TC30, P4TD2D, R40191, R40223, R4045J, R4054D, R40642.
The recall does not require immediate action, but you should check the lot numbers to confirm if your device is affected.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1889-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1889-2018 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.
