Northgate Technologies, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1148-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 15, 2021

Date Posted: March 3, 2021

Recall Number: Z-1148-2021

Event ID: 87231

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.

Status: Terminated

Product Quantity: 45 units

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the states of FL and OH.

Voluntary or Mandated:

Voluntary: Firm initiated