Criticare Technologies recall: NGenuity Patient Monitor with Capnography
Criticare Technologies, Inc. is recalling NGenuity Patient Monitor with Capnography – 1,007. The U.S. Food and Drug Administration published the recall on September 30, 2026; it began on May 6, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | NGenuity Patient Monitor with Capnography |
| Brand | Criticare Technologies |
| Company | Criticare Technologies, Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | May 6, 2026 |
| Published by FDA | September 30, 2026 |
| Quantity | 1,007 |
| Recall ID | 99545 |
Recalled products
- 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
- FDA recall number
- Z-3253-2026
- Codes, lots and dates
- 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
- Quantity
- 1,007
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99545
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Warwick, RI, United States
Why it was recalled
The reason the FDA lists: “Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.”
Where it was sold
Nationwide. Distribution as the FDA records it: “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.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99545, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
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About this recall
Is Criticare Technologies NGenuity Patient Monitor with Capnography recalled?
Yes. Criticare Technologies, Inc. recalled it on May 6, 2026; FDA published it September 30, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.