[Recalled] PKG, 3MM INSERT, DORSEY GRASPER, 20CM, P/N 0250282096 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | PKG, 3MM INSERT, DORSEY GRASPER, 20CM, P/N 0250282096 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 them to |
|---|---|
| Brand / manufacturer | Stryker Endoscopy |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0789-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 17 November 2014 |
| EAN / barcode | 0250282096 |
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.