The Recall Desk
HighFDA (Devices)·Z-1853-2022·Announced 2022-10-05

YelloPort Plus 5x70 Cannula recalled: labeled sterile but non-sterile

YelloPort Plus 5x70 Cannula devices are labeled as sterile but are actually non-sterile. This mislabeling poses an infection risk for laparoscopic surgical patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with mislabeled sterility status on surgical instruments used in sterile procedures. No illnesses or injuries have been reported, but use of non-sterile instruments in laparoscopic surgery represents a significant risk-of-harm scenario.

Plain-English summary

Surgical Innovations Ltd is recalling YelloPort Plus 5x70 Cannula devices (Model YC0507001) used in laparoscopic surgical procedures. The devices bear a sterile symbol on their labels but are not actually sterile.

The mislabeling creates a patient safety risk because sterile instruments are required for laparoscopic procedures. Use of non-sterile instruments in surgical procedures could result in infection.

Affected devices were distributed in Massachusetts. Healthcare facilities and patients should contact their device supplier or Surgical Innovations Ltd regarding return or replacement of affected devices.

The recalled product

Product
Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
Manufacturer
Surgical Innovations Ltd
Category
Medical Device — Laparoscopic Surgical Instrument
Hazard
  • sterile-mislabeling
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part/UDI-DI/Lot: YC0507001/05051986001890/735652

Distribution

Distributed in 1 state:

  • MA

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