Medical device recalls Moderate risk

Surgical Innovations Ltd recalls YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR

Recall date
March 28, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1602-2023
FDA classification
Class II
Brand / firm
Surgical Innovations Ltd
Sold / distributed
US: MA OUS: None

Why it was recalled

Optical Trocars sterility assurance can not be guaranteed

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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