CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report

Insufflator, laparoscopic The ConMed GS2000 recalled

Northgate Technologies is recalling Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq and Nebulae I, distributed nationwide in the US. The recall was initiated on 21 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: #89170HXB, #89556DYD, #89652FYA, #89661FYA, #89663FYA, #89664FYA, #89670FYA, #89672FYA, #89675FYA, #89677FYA, #89685FYB, #89697FYB, #89708GYA, #89713GYA, #89719GYB, #89720GYB, #89729GYB, #89732GYB, #89734GYB, #89737GYB, #89889IYD, #90165AZB, #90285BZD, #90387DZB, #90391DZB, #90415DZD, #90438DZD, #90469EZB, #90528EZD, #90555FZB, #90556FZB, #90557FZB, #90558FZB, #90561FZB, #90583GZC, #90621GZB, #90654HZB, #90739IZD, #90869KZD, #90931LZD, #90936LZD, #90954LZD, #90962LZD, #90972LZD, #91105CAD, #91108CAD, #91114CAD, #91120CAD, #91380FAC, #91406FAD, #91471GAC, #91544IAC

Quantity recalled49 devices

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-0866-2017
FDA event ID: 75716
Recalling firm: Northgate Technologies, Elgin, IL
Classification: Class II
Status: Terminated
Recall initiated: 21 Nov 2016
FDA classified: 21 Dec 2016
Reported: 28 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 Nov 2016	Recall initiated by company
21 Dec 2016	Classified by FDA	+30 days
28 Dec 2016	Published in enforcement report	+7 days

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

Reason for recall

Device could cause a patient overpressure situation without any visual or auditory indication or warning

Product as listed by the FDA

Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures

Where it was distributed

Worldwide Distribution - US including FL and MA. Internationally to Canada

Nationwide Florida Massachusetts

Questions about this recall

Is Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq and Nebulae I recalled?

Yes. Northgate Technologies recalled Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq and Nebulae I on 21 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0866-2017.

Why was it recalled?

Device could cause a patient overpressure situation without any visual or auditory indication or warning

Which lots are affected?

Serial Numbers: #89170HXB, #89556DYD, #89652FYA, #89661FYA, #89663FYA, #89664FYA, #89670FYA, #89672FYA, #89675FYA, #89677FYA, #89685FYB, #89697FYB, #89708GYA, #89713GYA, #89719GYB, #89720GYB, #89729GYB, #89732GYB, #89734GYB, #89737GYB, #89889IYD, #90165AZB, #90285BZD, #90387DZB, #90391DZB, #90415DZD, #90438DZD, #90469EZB, #90528EZD, #90555FZB, #90556FZB, #90557FZB, #90558FZB, #90561FZB, #90583GZC, #90621GZB, #90654HZB, #90739IZD, #90869KZD, #90931LZD, #90936LZD, #90954LZD, #90962LZD, #90972LZD, #91105CAD, #91108CAD, #91114CAD, #91120CAD, #91380FAC, #91406FAD, #91471GAC, #91544IAC

Where was it sold?

Worldwide Distribution - US including FL and MA. Internationally to Canada

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 21 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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