FDA Device recall Z-0693-2015
PKG, BIPOLAR FORCEPS, PADDLE, 45CM, P/N 0250080351
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, BIPOLAR FORCEPS, PADDLE, 45CM, P/N 0250080351 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-0693-2015 |
| 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, BIPOLAR FORCEPS, PADDLE, 45CM, P/N 0250080351. 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 | 816247 816248 817088 817415 817476 913562 913563 913828 913829 913830 915433 915678 915679 915680 915792…816247 816248 817088 817415 817476 913562 913563 913828 913829 913830 915433 915678 915679 915680 915792 915891 915892 915893 915949 1013276 1013838 1014368 1014638 1014639 1014750 1014943 1015257 1016064 1016065 1016066 1016067 1016198 1016250 1016735 1016737 1016738 1214971 1215297 1215300 1216025 1216026 1216027 1216028 1216822 1216823 1216824 1217033 1315269 1315270 1315932 1315985 1316201 1316305 1410091 1410847 1410875 1913567 |
|---|
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-0693-2015%22
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