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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1
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:
Part of a larger recall action
This product is one of 2 recalled by Surgical Innovations Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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