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[Recalled] PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing m

recall fda device united-states

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

Recall details

ProductPKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow t
Brand / manufacturerStryker Endoscopy
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0748-2015
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date17 November 2014
EAN / barcode0250080755

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods

This Class II recall concerns device products distributed in United States 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 Stryker Endoscopy

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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