{"recall":{"id":"fda-device-99176","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Covidien, LLC recalls EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-E","firm":"Covidien, LLC","date":"2026-05-13","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components.","code":"ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Catheters used after January 1, 2026.","quantity":"327","number":"Z-2950-2026","classification":"Class II"}],"reason":"The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Costa Rica, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Netherlands, New Zealand, Northern Ireland, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom.","nationwide":true,"states":[],"units":"327","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=99176","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c2d3ec747c0ffec3","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=99176","record":[{"status":"Ongoing","city":"Santa Clara","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99176","recalling_firm":"Covidien, LLC","address_1":"3062 Bunker Hill Ln","address_2":"","postal_code":"95054-1105","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Costa Rica, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Netherlands, New Zealand, Northern Ireland, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom.","recall_number":"Z-2950-2026","product_description":"EndoFLIP System that includes:  ENDOFLIP 1 SYSTEM EF-100  05391530810050  10884521809307  REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1  10884521808096  05391530810166  DL ENDOFLIP 1  10884521786684  Endoscopic measuring system, including catheter components.","product_quantity":"327","reason_for_recall":"The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.","recall_initiation_date":"20260513","center_classification_date":"20260814","report_date":"20260826","code_info":"ENDOFLIP 1 SYSTEM EF-100  05391530810050  10884521809307  REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1  10884521808096  05391530810166  DL ENDOFLIP 1  10884521786684  Catheters used after January 1, 2026.","more_code_info":""}]}}