Recall Z-2950-2026 ยท FFX System, Gastrointestinal Motility (Electrical)
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
| Date | Aug 14, 2026 (initiated May 13, 2026) |
| Status | Open, Classified |
| Reason | Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures. |
| Root cause | Under Investigation by firm |
| Action | On 05/13/2026, an "URGENT: MEDICAL DEVICE CORRECTION" letter was emailed/mailed to inform customer that EF-100 modules are affected by an end-of-life (EOL) software issue that prevents the units from recognizing Endoflip and Esoflip catheters after 01-January-2026, causing them to appear as expired. On 07/145/2026, an "Update to Urgent: Medical Device Correction" letter was sent via UPS 2-Day delivery updated potential patient harms Customers are instructed that: "May use the EF-300 system, if they have one. It is recommended to consult their biomedical staff for assistance in adjusting the |
| Quantity | 327 |
| 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, Col |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183072 | EndoFLIP System Crospon, Ltd., Feb 15, 2019 |