FDA Medical devices recall ·
EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050… recall
- Recall number
- Z-2950-2026
- Date
- (initiated May 13, 2026)
- Company / brand
- Covidien, LP
3062 Bunker Hill Ln, Santa Clara, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 327
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
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.
States: Alaska Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina Nebraska New Hampshire New Jersey New York Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2950-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.