CLASS II Device recall · Reported 4 May 2016 · FDA Enforcement Report

PneumoSure XL High Flow Insufflator recalled by Stryker Endoscopy

Stryker Endoscopy is recalling PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator, distributed nationwide in the US. The recall was initiated on 28 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesHPUs affected lot numbers 0005051337-000505052795; PneumoSure insufflators affected serial numbers 1510CE0342-1601CE0581

Quantity recalled489

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1566-2016
FDA event ID: 73674
Recalling firm: Stryker Endoscopy, San Jose, CA
Classification: Class II
Status: Terminated
Recall initiated: 28 Mar 2016
FDA classified: 25 Apr 2016
Reported: 4 May 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

28 Mar 2016	Recall initiated by company
25 Apr 2016	Classified by FDA	+28 days
4 May 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution. US nationwide including Puerto Rico, China, Hong Kong, India, Japan, Korea, Romania, Vietnam, Singapore, Taiwan, Netherlands, Peru, Australia, Canada, Mexico, Argentina, Chile, Poland, South Africa, and Guatemala.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

HPUs affected lot numbers 0005051337-000505052795; PneumoSure insufflators affected serial numbers 1510CE0342-1601CE0581

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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