Recall Z-1602-2023— Surgical Innovations Ltd

Name: FDA recall Z-1602-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-28

Class II · Ongoing

Class II FDA medical device recall by Surgical Innovations Ltd, initiated 2023-03-28. It names one FDA 510(k) clearance: K210495. Product: YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR. Reason: Optical Trocars sterility assurance can not be guaranteed.

Recalling firm: Surgical Innovations Ltd
Classification: Class II
Status: Ongoing
Initiated: 2023-03-28
Firm location: Leeds, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K210495 — Port Access SystemSurgical Innovations Limited·cleared 2021-06-18

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

YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR

Reason for recall

Optical Trocars sterility assurance can not be guaranteed

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