FDA recall Z-3253-2026

Product

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.

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.

Key facts

Status

Ongoing

Initiation date

2026-05-06

Report date

2026-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warwick, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3253-2026