EndoFLIP System
The EndoFLIP System can incorrectly flag catheters as expired, making them unavailable for clinical procedures.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Covidien, LLC of Santa Clara, California, recalled the EndoFLIP System because the system's 24-hour usage limit incorrectly flags catheters as expired, making them unavailable for clinical procedures. The recall began May 13, 2026, and was added to the FDA's Enforcement Report on August 14, 2026.
The affected products include the ENDOFLIP 1 SYSTEM EF-100, the REFURBISHED SYSTEM RFG-EF100, and the DL ENDOFLIP 1, which are endoscopic measuring systems with catheter components. The products were distributed nationwide in the United States, including in states such as Alaska, California, Florida, and Texas, as well as internationally in countries like Argentina, Australia, Canada, France, Germany, and the United Kingdom.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
EndoFLIP System that includes
- UDI-DI
- 05391530810050
- 10884521809307
- 10884521808096
- 05391530810166
- 10884521786684
Details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution including in the states of 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, and West Virginia. 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.
- Event ID
- 99176
- Recall No.
- Z-2950-2026
- Company
- Covidien, LLCSanta Clara, California
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
