nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-S… recall

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

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

Quantity: 1,007

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Company

Criticare Technologies, Inc., Warwick, RI

Date

Wednesday, September 30

Severity

Class II
the product could cause temporary or reversible health problems.

Where sold

Nationwide
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.

Status

Ongoing

Recall number

Z-3253-2026

Source

U.S. Food and Drug Administration