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.
Check against the official notice below — it lists the full affected range.
Covidien, LLC is recalling EndoFLIP System units and related catheters due to a 24-hour usage limit that causes catheters to be incorrectly flagged as expired, making them unavailable for clinical procedures. The recalled systems include the ENDOFLIP 1 SYSTEM EF-100, REFURBISHED SYSTEM RFG-EF100, and ENDOFLIP 1 DL models, with approximately 327 units distributed worldwide across numerous U.S. states and countries including Canada, Australia, and most of Western Europe.
The catheters affected in this recall are those used after January 1, 2026. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
Reason for recall: The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures. Distribution: 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 Zea Quantity: 327 Lot/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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.