UnratedMedical device recall · FDA · Published January 15, 2021
Steris CO2MPACT Endoscopic Insufflator Recall: Incorrect Material Risk
Steris recalls CO2MPACT Endoscopic Insufflator systems with specific lot codes due to incorrect tubing material not tested for use. Affected units may pose risks during medical procedures.
“Steris CO2MPACT Endoscopic Insufflator Recall: Incorrect Material Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63380-steris-co2mpact-endoscopic-insufflator-recall-incorrect-material-risk. Based on FDA recall #Z-1148-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1148-2021%22&limit=1).
The FDA announced on Jan. 15, 2021, that Northgate Technologies, Inc. voluntarily recalled Steris CO2MPACT Endoscopic Insufflator systems due to an internal tubing component made of incorrect material. The agency classified the recall as Class II.
How to tell if you have it
Brand: Steris
Product: CO2MPACT Endoscopic Insufflator system
Catalog Numbers: 72-00310-0 / 710300
Lot Codes: 93830JEK to 93854JEK; 93899LEK to 93908LEK; 93909LEK to 93918LEK
Quantity: 45 units
The hazard
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device, according to the FDA.
Context
GovInfoNow's records show Northgate Technologies, Inc. has 3 other recalls on record since 2020-03-10. Other recent recalls of similar products include Erbe Medical ERBEFLO 2 Endoscopy Pump Tubing Recall (2026-03-31), Olympus Single Use Sphincterotome V Recall (2026-01-07), and Erbe Medical CleverCap CO2 Tubing/Cap Set Recall (2026-03-31).
How to tell if you have this one
Check the lot codes on the device: 93830JEK to 93854JEK, 93899LEK to 93908LEK, or 93909LEK to 93918LEK. The product is designed for use with gastrointestinal endoscopes to inflate the gastrointestinal tract with CO2.
Brand
Steris
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution in the states of FL and OH.
Recall number
Product, codes & lots
Quantity
Z-1147-2021
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
25 units
Z-1148-2021
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
45 units
Based on the official FDA remedy
What to do — step by step
Check Lot Code
Identify the lot code on the device to determine if it falls within the affected ranges: 93830JEK to 93854JEK, 93899LEK to 93908LEK, or 93909LEK to 93918LEK.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of FL and OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Ohio.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1148-2021 (January 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1148-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
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