- Recalling firm
- Criticare Technologies, Inc.
- Reason for recall
- Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
- Affected products (lot / model / serial)
- 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
- Units affected
- 1,007
- Distribution pattern
- 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.
- Firm location
- Warwick, RI, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3253-2026
- Recall initiated
- May 6, 2026
- FDA classification date
- September 22, 2026
- FDA report date
- September 30, 2026
- FDA event ID
- 99545
- Last updated on HTM Vibe
- October 6, 2026
