Steris CO2MPACT Endoscopic Insufflator system — Class II medical device recall Z-1148-2021
Terminated recall by Northgate Technologies, Inc., reported 2021-03-03, distributed nationwide. An internal tubing component in the flow path was made with incorrect material which was not tested for use wi
| Recall number | Z-1148-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Northgate Technologies, Inc., Elgin, IL, United States |
| Recall initiated | 2021-01-15 |
| Classified | 2021-02-24 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2022-10-31 |
| Distributed | Nationwide (US) |
| Quantity | 45 units |
| Lot numbers | 93830JEK, 93854JEK, 93899LEK, 93908LEK, 93909LEK, 93918LEK |
| Model numbers | 710300, 72-00310-0 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1148-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.