FDA Device recall Z-0684-2015
PKG, BABCOCK FORCEPS, P/N 0250080321
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, BABCOCK FORCEPS, P/N 0250080321 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-0684-2015 |
| 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, BABCOCK FORCEPS, P/N 0250080321. 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 | 140571 140572 140590 442506 542896 643523 646838 741305 741307 744923 842628 842632 842638 842640 847869…140571 140572 140590 442506 542896 643523 646838 741305 741307 744923 842628 842632 842638 842640 847869 847870 847872 847873 847877 847878 847880 847881 847885 847886 1041276 1042935 1042951 1045190 1046166 1046900 1046901 1140664 1140821 1142174 1142665 1143446 1143728 1144692 1145109 1146164 1146165 1146388 1146900 1146901 1147163 1240407 1240955 1241953 1241954 1242409 1243807 1244132 1244241 1244441 1245480 1246060 1246405 1340290 1341254 1341835 1341836 1343535 1343993 1346493 1440592 1440788 1440789 |
|---|
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-0684-2015%22
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