FDA Device recall Z-0624-2015
PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234 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-0624-2015 |
| 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, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. 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 | 42178 42259 42260 42263 42267 42325 42326 42791 70109 713091 72309 90809 1192010 140575 140800 140807 1…42178 42259 42260 42263 42267 42325 42326 42791 70109 713091 72309 90809 1192010 140575 140800 140807 140864 141289 141292 141401 0200154B 0200176B 0200177B 0245386C 0246314C 0246934C 0246939C 0246940C 0246942C 0247044C 0247047C 0247049C 0340029C 0340679C 0340680C 0340681C 0340682C 0340683C 0341237C 0341241C 0341908C 0341912C 4122011 04242012E 04282011E 0441389C 0441455C 0441456C 441457 0441461C 0441464C 0441465C 0441466C 0441467C 0441468C 0441471C 0441472C 0443282C 0443519C 5022011 5112010 5212010 52120101 52120102 52120103 52120104 05232013D 5252010 0540672D 0540867D 0540868D 0540869D 0540871D 0540872D 0540873D 0540874D 0540877D 0540878D 0540880D 0540881D 0540884D 06040590D 06122012E 6162014 6172011 6272012 06272012E 0640590D 0640591D 0640595D 0640596D 0640606D 0640607D 0640608D 640609 0640610D 0640611D 0640612D 0640613D 0640614D 0640615D 0647215D 06CON06064 06CON06123 06CON06666 |
|---|
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-0624-2015%22
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