FDA Device recall Z-1566-2016
PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator
- FDA Device
- Class II
- terminated
- Published 2016-05-04
On 2016-05-04 the FDA classified a Class II recall of PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator by Stryker Endoscopy, citing when operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1566-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-28 |
| Published | 2016-05-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Endoscopy |
| Distribution | US |
Product
PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High Flow Insufflator is a device that serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy. The insufflator consists of a console, that is intended to be connected to a CO2 gas source, and has a tubeset inserted to transport CO2 gas from the insufflator to the connecting trocar.
Reason
When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.
Identifiers
| code_info | HPUs affected lot numbers 0005051337-000505052795; PneumoSure insufflators affected serial numbers 1510CE0342-1601CE0581 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1566-2016%22
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