Class II — Criticare Technologies, Inc.
| Recalling firm | Criticare Technologies, Inc. |
|---|---|
| Registered facility | CRITICARE TECHNOLOGIES, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay. |
| 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 |
| Quantity | 1,007 |
| 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. |
| Initiated | 2026-05-06 |
| Classified | 2026-09-22 |
| Recall number | Z-3253-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Criticare Technologies, Inc. (Z-3253-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99545/
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