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[Recalled] YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR — Optical Trocars sterility assurance can not be guaranteed | FDA 2023-03-28

recall fda device united-kingdom

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductYelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
Brand / manufacturerSurgical Innovations Ltd
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1602-2023
Country of noticeUnited Kingdom
Risk levelClass II
Hazard typerecall
Notice date28 March 2023
EAN / barcode05051986013428

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Optical Trocars sterility assurance can not be guaranteed

This Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Surgical Innovations Ltd

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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