FDA Medical Device Recalls (openFDA)
Criticare Technologies, Inc.: 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
- Recall number
- Z-3253-2026
- Recalling firm
- Criticare Technologies, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2026-05-06
- Posted
- 2026-09-22
- Terminated
- not on file
- Reason
- Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
- Root cause
- Process design
- Action
- Firm posted its initial notice on May 6, 2026. A follow-up letter was sent on August 31, 2026 with additional instructions. Customers were instructed to do the following: 1. Be aware of the Checkline Error alarm. If it appears on your CO2 section at startup, follow the steps provided in the letter. 2. Verify your backup plan. Confirm that your practice has access to an alternate CO2 monitoring source. 3. Retain the letter and note your unit s serial number for your records. 4. Contact the firm if you have any questions.
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K030613"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 3012238587
- Firm city
- Warwick
- Firm state
- RI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28