FDA Device recall Z-0602-2015
PKG, PORTIO ACORN SMALL ONLY, P/N 0250080139
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, PORTIO ACORN SMALL ONLY, P/N 0250080139 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-0602-2015 |
| 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, PORTIO ACORN SMALL ONLY, P/N 0250080139; 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 | 34504 35874 36526 39114 41754 43588 44933 45493 47090 47110 48141 48644 58733 71066 71696 73836 78683…34504 35874 36526 39114 41754 43588 44933 45493 47090 47110 48141 48644 58733 71066 71696 73836 78683 80420 83082 35298 36525 37553 38130 45247 47804 48542 50949 76176 76645 76892 82553 83081 84279 |
|---|
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-0602-2015%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.