Covidien recalls Auto Suture Structural Balloon Trocar (OMS-T10SB) due to potential seal disengagement when mesh products are used incorrectly. Affected units include specific lot numbers. Consumers should contact for details.
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Covidien is recalling its Auto Suture Structural Balloon Trocar (product number OMS-T10SB) because it can disengage when mesh products are used incorrectly. This could lead to improper medical procedures if the device fails during surgery.
The trocar's seal may become loose if mesh products are not properly aligned with the device during surgical procedures. This could cause the device to malfunction, potentially leading to improper tissue handling or bleeding.
Medical professionals using the device during surgery are most at risk. Patients undergoing procedures with this trocar may be affected if the seal disengages.
Check for product number OMS-T10SB on the device. Affected units include specific lot numbers listed in the recall notice (e.g., P0B1097Y, P0L1408, etc.).
Look for the product number OMS-T10SB on the device to confirm if it is affected.
Reach out to Covidien for specific instructions on how to handle the device if it is affected.
The device may be unsafe if mesh products are used incorrectly, which could cause the seal to disengage during surgery.
Check for product number OMS-T10SB and specific lot numbers listed in the recall notice (e.g., P0B1097Y, P0L1408, etc.).
Contact Covidien directly for instructions on how to handle the device if it is affected by the recall.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1465-2024 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1465-2024 from Covidien. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
