NGenuity Patient Monitor with Capnography (ETCO2)
The patient monitor can show a Checkline Error alarm at setup, which may delay the procedure.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Criticare Technologies, Inc., of Warwick, Rhode Island, recalled its nGenuity Patient Monitor with Capnography (ETCO2) models CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, and CAT 8100EP1R due to a complaint trend where a "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable and potentially causing procedure delay.
The recall began on May 6, 2026, and was added to the FDA's Enforcement Report on September 22, 2026. Distribution was nationwide, including Puerto Rico.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
nGenuity Patient Monitor with Capnography (ETCO2) Cat 8100E1-ST-US, Cat 8100E1-US, Cat 8100EP1, Cat 8100EP1-ST, Cat 8100EP1-ST-US, Cat 8100EP1-US, Cat 8100EP1R
- Lot
- All units with CO2 option SN beginning with 424, 125, 225, 325, 425, 126, 226, 326, 426, date range 2024-1st qt 2026
Details
- Company began the recall
- Sold in
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 Rico.
- Event ID
- 99545
- Recall No.
- Z-3253-2026
- Company
- Criticare Technologies, Inc.Warwick, Rhode Island
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
