FDA Device recall Z-0697-2015
PKG, 5MM INSULATED SHAFT 45CM, FOR BIPOLAR FORCEPS, P/N 0250080370
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, 5MM INSULATED SHAFT 45CM, FOR BIPOLAR FORCEPS, P/N 0250080370 by Stryker Endoscopy, citing 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 Ethyl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0697-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-17 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Endoscopy |
| Distribution | US |
Product
PKG, 5MM INSULATED SHAFT 45CM, FOR BIPOLAR FORCEPS, P/N 0250080370. 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 be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
Reason
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
Identifiers
| code_info | 813640 816590 816591 816592 817084 817085 817086 817206 915434 1014641 1014642 1014643 1015775 1015776 10…813640 816590 816591 816592 817084 817085 817086 817206 915434 1014641 1014642 1014643 1015775 1015776 1015777 1016199 1114632 1114633 1114634 1213976 1213977 1216723 1216724 1216725 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0697-2015%22
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