CLASS II Device recall · Reported 3 Mar 2021 · FDA Enforcement Report
ConMed abdominal insufflator recalled by Northgate Technologies
Northgate Technologies is recalling ConMed abdominal insufflator, distributed nationwide in the US. The recall was initiated on 15 Jan 2021 and the FDA has classified it as Class II.
Check your package
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-1147-2021
- FDA event ID
- 87231
- Recalling firm
- Northgate Technologies, Elgin, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jan 2021
- FDA classified
- 24 Feb 2021
- Reported
- 3 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 15 Jan 2021 | Recall initiated by company | |
| 24 Feb 2021 | Classified by FDA | +40 days |
| 3 Mar 2021 | 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
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Product as listed by the FDA
ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery).
Where it was distributed
US Nationwide distribution in the states of FL and OH.
Questions about this recall
Is ConMed abdominal insufflator recalled?
Yes. Northgate Technologies recalled ConMed abdominal insufflator on 15 Jan 2021. The recall is Class II and its status is Terminated. Recall number Z-1147-2021.
Why was it recalled?
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Which lots are affected?
Lot Codes: 9855JEG to 93879JEG
Where was it sold?
US Nationwide distribution in the states of FL and OH.
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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