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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Northgate Technologies, Inc.: An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.

Agency Publication Date: February 24, 2021
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Affected Products

Product: 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).

Lot Codes: 9855JEG to 93879JEG

Lot Numbers:
Codes
Product: Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

Lot Codes: 93830JEK to 93854JEK; 93899LEK to 93908LEK; 93909LEK to 93918LEK

Lot Numbers:
Codes

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87231
Status: Resolved
Manufacturer: Northgate Technologies, Inc.
Manufactured In: United States
Units Affected: 2 products (25 units; 45 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.