Covidien, Llc: System, Gastrointestinal Motility (electrical)
- Recalling firm
- Covidien, LLC
- Product
- EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-13
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/33c11160-7484-4c2c-866d-824d0ee91251