FDAClass IIMay 24, 2023

YelloPort Elite recall: Sterility Concern

YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR

Why was YelloPort Elite recalled?

Optical Trocars sterility assurance can not be guaranteed

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 738182 ; UDI-DI: (01) 05051986013398

Product
YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
Recalling firm
Surgical Innovations Ltd
Quantity
2380 units
Distribution
US: MA OUS: None
Recall date
May 24, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls