FDAMay 13, 2026
Covidien EndoFLIP System Recall
FDA published this notice on May 13, 2026 for United States.
This notice is kept at its address for anyone who saved the link. AreaZine no longer holds the agency's full record for it, so the page shows what AreaZine recorded and links to the agency's own page, the one to read.
What AreaZine recorded
- Agency
- FDA
- Place
- United States
- Date
- May 13, 2026
- Recall class
- Class II
- Reason given by the agency
- 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 Zealand, Northern Ireland, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom.
- Official source
- the notice at its source
Official warnings by state, with every type counted since 2008Search notices, places and declaration numbers
Source: FDA.