Surgical Optical Trocars Recalled Due to Sterility Assurance Failure
Surgical Innovations Ltd is recalling 2380 YelloPort Elite optical trocars due to inability to guarantee sterility. Patients using contaminated surgical instruments may develop serious infections.
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: This is a Class II medical device recall involving a surgical instrument where sterility assurance cannot be guaranteed. The product represents a risk of harm—contaminated surgical instruments can cause serious infection or sepsis during invasive procedures. No illnesses or injuries have been reported, placing this in the High category.
Plain-English summary
Surgical Innovations Ltd is recalling 2380 units of the YelloPort Elite Optical Trocar (REF: EO0507005, 5x70 size) due to inability to guarantee sterility of the devices.
The recall affects trocars with Lot #738182. These devices are manufactured for use during surgical procedures. If a trocar is not sterile at the time of use, it could introduce bacteria or other pathogens into the surgical site, potentially causing serious infection.
The affected trocars were distributed in Massachusetts. Healthcare facilities and surgical centers in that region may have received these devices.
Healthcare providers who have received affected units should immediately quarantine and discontinue use of any YelloPort Elite trocars from Lot #738182. Contact Surgical Innovations Ltd for replacement units or destruction instructions. Patients who have undergone surgery with these trocars should monitor for signs of infection and contact their healthcare provider if symptoms develop.
The recalled product
- Product
- YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
- Manufacturer
- Surgical Innovations Ltd
- Affected units
- 2,380
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) 05051986013398
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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