Ethicon recalls 5mm Endopath Xcel trocars with Optiview Technology due to potential surgery prolongation from insufficient lubrication. Affected lots listed; no immediate action needed but check for lubrication issues.
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 that may cause surgery to last longer if not properly lubricated. There's also a small chance of tiny particles entering the body during repeated use if the seal is damaged.
Insufficient lubrication can cause the trocar to become stuck during surgery, requiring repeated replacements which prolong the procedure. Repeated insertions might damage the seal, potentially introducing tiny particles into the body.
Surgical teams using the recalled trocars during procedures. Patients undergoing surgery with these specific models are at risk if lubrication is inadequate.
Check the lot numbers listed: P4T58Y through P4TA9R and others. The product is a 5mm Endopath Xcel trocar with Optiview Technology, Bladeless Trocar, Stability Sleeve, 100mm shaft length, and 2B5LT model.
Ensure the trocar is properly lubricated before use to prevent prolonged surgery or seal damage.
No, the recall does not require immediate discontinuation. Proper lubrication can prevent issues.
Insufficient lubrication may prolong surgery due to trocar replacement and could cause a small risk of tiny particles entering the body.
Affected lots include P4T58Y, P4T59E, P4T627, P4T665, P4T66C, P4T716, P4T71L, P4T780, P4T83K, P4T844, P4T87R, P4T88E, P4T88G, P4T88H, P4T927, P4T942, P4T946, P4T94D, P4TA19, P4TA3V, P4TA4N, P4TA4R, P4TA9K, P4TA9R, P4TC2E, P4TC2T, P4TC67, P4TC6Z, P4TD1M, R4000W, R40045, R4004G, R4007H, R4013R, R40172, R4017C, R4021R, R4021U, R4023D, R40267, R4026E, R4031V, R4036K, R4036V, R40397, R4041C, R4041J, R4044A, R4044K, R4048E.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1885-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1885-2018 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.
