Class IIDeviceOngoing

Criticare Technologies, Inc.

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

Reason for recall

Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.

Details

Recall number: Z-3253-2026
Event ID: 99545
Recall initiated: May 6, 2026
Classified: Sep 22, 2026
Reported: Sep 30, 2026
Quantity: 1,007
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 Rico.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Warwick, RI, United States
Lot / code info: UDI-DI +B4388100EP1US02 All units with CO2 option SN beginning with 424, 125, 225, 325, 425, 126, 226, 326, 426, date range 2024-1st qt 2026