Surgical Innovations Ltd FDA Recalls

5 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileRClass IIMar 28, 2023Optical Trocars sterility assurance can not be guaranteed	Optical Trocars sterility assurance can not be guaranteed	Class IIDevices	Mar 28, 2023
YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileRClass IIMar 28, 2023Optical Trocars sterility assurance can not be guaranteed	Optical Trocars sterility assurance can not be guaranteed	Class IIDevices	Mar 28, 2023
YelloPort Elite Universal Seal. For use in laparoscopic procedures.Class IIJun 2, 2022There is the potential that YelloPort Elite Universal Seals	There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect	Class IIDevices	Jun 2, 2022
Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.Class IIJan 20, 2022Laparoscopic devices have a sterile symbol included on label	Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.	Class IIDevices	Jan 20, 2022
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. FoClass IIJan 20, 2022Laparoscopic devices have a sterile symbol included on label	Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.	Class IIDevices	Jan 20, 2022