YelloPort Elite Optical Trocars Recalled for Sterility Assurance Failure
YelloPort Elite optical trocars (3,405 units) are recalled because sterility assurance cannot be guaranteed. The surgical instruments were distributed in Massachusetts.
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 recall of surgical instruments with inability to guarantee sterility. While no reported illnesses or injuries have been documented, non-sterile surgical instruments present a serious risk of infection during invasive procedures, meeting the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
YelloPort Elite optical trocars (model REF: EO0509505) manufactured by Surgical Innovations Ltd are being recalled. The recall affects 3,405 units, including those from Lot # 738182 (UDI-DI: 05051986013428).
Surgical Innovations Ltd issued this recall because sterility assurance cannot be guaranteed for these devices. Optical trocars are surgical instruments used in laparoscopic and minimally invasive procedures, where sterility is critical to preventing surgical site infections.
The affected units were distributed in the United States, specifically in Massachusetts.
Do not use affected devices. Healthcare facilities and individuals with these devices should not use them for surgical procedures and should contact Surgical Innovations Ltd or the FDA for guidance.
The recalled product
- Product
- YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
- Manufacturer
- Surgical Innovations Ltd
- Hazard
- sterility-assurance-failure
- 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)
- Lot # 738182
- UDI-DI: (01) 05051986013428
Distribution
Distributed in 1 state:
- MA
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