Recall Z-1852-2022— Surgical Innovations Ltd

Name: FDA recall Z-1852-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-20

Class II · Ongoing

Class II FDA medical device recall by Surgical Innovations Ltd, initiated 2022-01-20. It names one FDA 510(k) clearance: K190592. Product: Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.. Reason: Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile..

Recalling firm: Surgical Innovations Ltd
Classification: Class II
Status: Ongoing
Initiated: 2022-01-20
Firm location: Leeds, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K190592 — YelloPort Elite Port Access SystemSurgical Innovations Limited·cleared 2019-04-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.

Reason for recall

Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

Data sourced from openFDA. This site is unofficial and independent of the FDA.