{"url_path":"/fda/device/recalls/Z-2950-2026","section_key":"summary","section_title":"DEVICE Recall: Covidien, LLC — 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.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-13","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2950-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Covidien, LLC"},"word_count":184,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2950-2026\n\n**Recalling firm:** Covidien, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-13\n**Report date:** 2026-08-26\n\n## Product\nEndoFLIP 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.\n\n## Reason\nThe system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.\n\n## Affected lots\nENDOFLIP 1 SYSTEM EF-100  05391530810050  10884521809307  REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1  10884521808096  05391530810166  DL ENDOFLIP 1  10884521786684  Catheters used after January 1, 2026.\n\n## Distribution\nWorldwide - 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."}