FDA Device recall Z-0611-2015
PKG, FIXABLE CONE FOR 11MM HASSON, P/N 0250080180
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, FIXABLE CONE FOR 11MM HASSON, P/N 0250080180 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-0611-2015 |
| 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, FIXABLE CONE FOR 11MM HASSON, P/N 0250080180. 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 | 24420 38391 39501 40785 42998 43902 47088 56403 57978 59038 59246 67133 67379 71902 73443 74973 76048 76964 78098 84029 85321 88695 Q11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Stryker Endoscopy
- PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator
FDA Device · Class II · 2016-05-04 · Stryker Endoscopy - SERFAS 90 degree Energy Probe, Part Number 279-350-101
FDA Device · Class II · 2015-07-01 · Stryker Endoscopy - PKG, 5MM INSERT, MINI METZENBAUM SCISSORS, CURVED, 45CM, P/N 0250080574 Laparoscopic Manual Instruments are intended for cutting, holding,…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manip…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 3MM INSERT, FUNDUS GRASPER, 29CM, P/N 0250282050 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manip…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0611-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.