FDA Device recall Z-0656-2015
PKG, GRASPER FORCEPS, SERRATED, P/N 0250080286
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, GRASPER FORCEPS, SERRATED, P/N 0250080286 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-0656-2015 |
| 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, GRASPER FORCEPS, SERRATED, P/N 0250080286. 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 | 246416 340639 344735 542132 544416 742144 841812 842091 845858 847684 940079 942282 943532 944666 944831…246416 340639 344735 542132 544416 742144 841812 842091 845858 847684 940079 942282 943532 944666 944831 945443 1040391 1040415 1041478 1042250 1042663 1042664 1042665 1042669 1042677 1143123 1144211 1145077 1145684 1146119 1147041 1240547 1241427 1242129 1242645 1243802 1243954 1244189 1245024 1245604 1246054 1246180 1343405 1343556 1344028 1344292 1344459 1345527 1346103 1346649 1440443 1441169 1442254 1442805 645372 |
|---|
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-0656-2015%22
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