YelloPort Elite Laparoscopic Trocar and Adaptor Non-Sterile Recall
Surgical Innovations Ltd is recalling YelloPort Elite laparoscopic surgical instruments because devices labeled as sterile are non-sterile, posing infection risk if used in surgery.
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: Non-sterile surgical instruments used in invasive laparoscopic procedures pose direct risk of serious infection. No illnesses or injuries have been reported to date. This is a risk-of-harm medical device where the sterility defect creates significant potential for patient harm, classified as High severity.
Plain-English summary
Surgical Innovations Ltd is recalling the YelloPort Elite 12x75 Pencil Point Trocar (Part ET1207503) and YelloPort Elite Hasson Adaptor 10mm (Part EA10NH) used in laparoscopic surgical procedures. The devices have a sterile symbol on packaging but are non-sterile, which creates a risk of serious infection if the devices are used in surgery.
The recall affects 19 units that were distributed in Massachusetts. Affected devices can be identified by their UDI-DI/Lot numbers: ET1207503/05051986012438/735479 and EA10NH/05051986012100/734029.
Healthcare facilities and surgical teams should immediately stop using affected devices and contact Surgical Innovations Ltd. If any of these devices were used in patient procedures, healthcare providers should monitor patients for signs of infection or complications and consult appropriate medical guidance.
The recalled product
- Product
- Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
- Manufacturer
- Surgical Innovations Ltd
- Hazard
- non-sterile-device
- labeling-defect
- 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 (2)
- Part/UDI-DI/Lot: ET1207503/05051986012438/735479
- EA10NH/05051986012100/734029
Distribution
Distributed in 1 state:
- MA
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