Use cautionMedical device recall · FDA · Published May 6, 2026
Criticare nGenuity Patient Monitor with Capnography Recall: Checkline Error Causes CO2
Criticare recalls patient monitors with CO2 monitoring that may show Checkline Error alarms, disabling CO2 readings during procedures. This could delay surgery. Affected models include CAT 8100E1-ST-US and others sold from 2024 to 2026.
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
“Criticare nGenuity Patient Monitor with Capnography Recall: Checkline Error Causes CO2.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1293273-criticare-ngenuity-patient-monitor-with-capnography-recall-checkline-error-causes. Based on FDA recall #Z-3253-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3253-2026%22&limit=1).
The FDA announced on May 6, 2026, that Criticare Technologies, Inc. is recalling nGenuity Patient Monitors with Capnography due to a hazard that may render CO2 monitoring inoperable. The agency issued recall number Z-3253-2026 for the voluntary Class II action.
How to tell if you have it
Brand: Criticare
Product: nGenuity Patient Monitor with Capnography (ETCO2)
Serial number prefixes: 424, 125, 225, 325, 425, 126, 226, 326, 426
Date range: 2024-1st qt 2026
Quantity: 1,007 units
The hazard
The recall addresses a complaint trend where a "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. This malfunction may result in procedure delay.
Context
GovInfoNow's records show other recent recalls of similar products include Sophysa Pressio 2 ICP Monitor Reboots (2025-11-17), Philips IntelliVue Multi Measurement Server X2 Recall (2025-10-31), and Philips IntelliVue MX40 (2025-10-31).
How to tell if you have this one
Check for model numbers CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, or CAT 8100EP1-ST-US. Units with CO2 option serial numbers starting with 424, 125, 225, 325, 425, 126, 226, 326, 426 sold between early 2024 and late 2026.
Brand
Criticare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Monitor Status
Look for a 'Checkline Error' alarm during setup that disables CO2 monitoring.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 40 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states and territory of AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and Puerto…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
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-3253-2026 (May 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3253-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 6, 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.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.