The Recall Desk
ModerateFDA (Devices)·Z-3253-2026·Announced 2026-09-30

Criticare nGenuity Patient Monitor Recalled for Capnography Setup Error

Criticare Technologies is recalling 1,007 nGenuity Patient Monitors because a setup error renders the CO2 monitoring function inoperable, potentially delaying procedures.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the hazard is a 'procedure delay' with no mention of injury, death, or serious harm, fitting the Moderate criteria for low-risk operational issues.

Plain-English summary

Criticare Technologies, Inc. is recalling 1,007 units of the nGenuity Patient Monitor with Capnography (ETCO2). The affected models include CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, and CAT 8100EP1R. The recall covers units with the CO2 option and serial numbers beginning with 424, 125, 225, 325, 425, 126, 226, 326, or 426, manufactured between 2024 and the first quarter of 2026.

The recall is due to a complaint trend where a "Checkline Error" alarm appears during device setup. This error renders the CO2 monitoring function inoperable. The FDA classifies this as a Class II recall. The primary risk associated with this defect is a delay in medical procedures.

The affected devices were distributed nationwide in the United States, 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. Healthcare facilities should check their inventory for the specific serial number prefixes and date ranges listed above and contact Criticare Technologies for instructions on how to resolve the issue.

The recalled product

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
Manufacturer
Criticare Technologies, Inc.
Category
Medical Device — Patient Monitor
Hazard
Affected units
1,007

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 41 states specifically:

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