FDA Device recall Z-0685-2015
PKG, GRASPER FORCEPS, DELICATE, FENESTRATED, P/N 0250080322
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, GRASPER FORCEPS, DELICATE, FENESTRATED, P/N 0250080322 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-0685-2015 |
| 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, DELICATE, FENESTRATED, P/N 0250080322. 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 | 43998 44285 740839 840085 844271 845502 942652 943741 944218 944701 945747 945987 1040596 1042092 1042500…43998 44285 740839 840085 844271 845502 942652 943741 944218 944701 945747 945987 1040596 1042092 1042500 1043510 1045652 1141382 1143801 1144307 1144308 1145636 1146675 1240767 1241940 1242644 1244526 1244963 1246365 1340542 1341581 1341981 1342752 1343399 1343699 1346235 1440401 |
|---|
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-0685-2015%22
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