{"recall":{"id":"fda-device-99545","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Criticare Technologies, Inc. recalls nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US","firm":"Criticare Technologies, Inc.","date":"2026-05-06","reported":"2026-09-30","status":"Ongoing","classification":"Class II","products":[{"name":"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","code":"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","number":"Z-3253-2026","classification":"Class II"}],"reason":"Complaint trend where \"Checkline Error\" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"1,007","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99545","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"de3a68a6d8db392b","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99545","record":[{"status":"Ongoing","city":"Warwick","state":"RI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99545","recalling_firm":"Criticare Technologies, Inc.","address_1":"333 Strawberry Field Rd Ste 11","address_2":"","postal_code":"02886-2459","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","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.","recall_number":"Z-3253-2026","product_description":"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","product_quantity":"1,007","reason_for_recall":"Complaint trend where \"Checkline Error\" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.","recall_initiation_date":"20260506","center_classification_date":"20260922","report_date":"20260930","code_info":"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","more_code_info":""}]}}