Surgical Innovations recalls YelloPort Elite Universal Seals for potential packaging holes that could compromise sterility during laparoscopic surgery. Affected units include all lots with UDI/DI:0505198:001562.
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
Surgical Innovations is recalling YelloPort Elite Universal Seals used in laparoscopic procedures because their packaging might have small holes that could affect sterility. This risk could lead to infections during surgery if the seal isn't properly sterile.
The packaging may have small holes that could compromise the sterility of the seal. If the seal isn't sterile, it could lead to infections during surgery. This is a potential risk but not guaranteed to happen.
Surgical professionals using YelloPort Elite Universal Seals for laparoscopic procedures are most at risk. All units with the UDI/DI:05051986001562 are affected.
Check for the product name 'YelloPort Elite Universal Seal' used in laparoscopic procedures. All lots with UDI/DI:05051986001562 are affected.
Inspect the packaging for small holes that might compromise sterility.
The recall indicates potential packaging holes that could affect sterility, but the product is not inherently unsafe. Affected units should be checked for packaging integrity.
Check for the product name 'YelloPort Elite Universal Seal' used in laparoscopic procedures with UDI/DI:05051986001562.
Inspect the packaging for small holes that might compromise sterility. If holes are found, contact Surgical Innovations for guidance.
We’ve drafted a message you can send Surgical Innovations to request your refund or repair — edit it as you like.
Subject: Recall Z-1396-2022 — Surgical Innovations Surgical Innovations Hello, I own a Surgical Innovations that is covered by recall Z-1396-2022 from Surgical Innovations. 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.
