FDA Device recall Z-0678-2015
PKG, FUNDUS FORCEPS, P/N 0250080315
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, FUNDUS FORCEPS, P/N 0250080315 by Stryker Endoscopy, citing stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 100….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0678-2015 |
| 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, FUNDUS FORCEPS, P/N 0250080315. 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
Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because 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 | 141309 646670 842621 842622 842623 842624 848151 848152 848153 848154 848158 848159 944681 945330 945750…141309 646670 842621 842622 842623 842624 848151 848152 848153 848154 848158 848159 944681 945330 945750 945828 945829 945830 945835 945836 1040394 1040541 1042480 1042926 1045981 1045982 1140693 1143447 1143582 1145552 1145982 1146297 1240548 1241307 1242395 1242465 1243545 1245973 1340289 1340717 1341251 1342684 1344461 134461 1345087 1345240 1345489 |
|---|
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-0678-2015%22
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