Criticare Technologies recalls

Recall found. Criticare Technologies is named in FDA Class II recall Z-3253-2026 covering nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US. Hazard: Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay. Identifying details: 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. Status: Ongoing.

Models with recalls

nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US (1)

All Criticare Technologies recalls

FDA Class II · Medical device · September 30, 2026

nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US recall — Criticare Technologies, Inc.

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

Official ID Z-3253-2026 · Official record ↗

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Compiled from official public-domain government data. Last checked October 22, 2026 at 12:00 PM UTC.