“Covidien EndoFLIP System: Catheters May Be Incorrectly Flagged as Expired.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/698290-covidien-endoflip-system-catheters-may-be-incorrectly-flagged-as-expired. Based on FDA recall #Z-2950-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2950-2026%22&limit=1).
The FDA announced on May 13, 2026, that Covidien LLC is recalling EndoFLIP Systems due to a hazard where catheters are incorrectly flagged as expired after 24 hours of use. This issue makes the catheters unavailable for clinical procedures.
How to tell if you have it
Brand: Covidien
Product: ENDOFLIP 1 SYSTEM EF-100 (REFURBISHED SYSTEM RFG-EF100)
Lot codes: 05391530810050, 10884521809307, 10884521808096, 05391530810166, 10884521786684
Catheters used after January 1, 2026
The hazard
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
Context
GovInfoNow's records show Covidien LLC has 52 other recalls on record since August 7, 2017. Recent recalls include the April 23, 2026 Mon-a-Therm Temperature Probe Recall for lack of FDA clearance and the April 23, 2026 Shiley Disposable Decannulation Plug Recall for incorrect DEHP labeling. Other recent recalls of similar products include the November 29, 2025 BD Ready-to-Use Hydrophilic Catheter recall for incorrect expiration date labeling and the March 5, 2026 Cook Medical Multipurpose Drainage Catheter recall for expiration dates exceeding shelf life.
How to tell if you have this one
Check for the EndoFLIP 1 System with model numbers 05391530810050, 10884521809307, or 108884521808096. The catheters were sold after January 1, 2026.
Brand
Covidien
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Date
Verify the catheter's production date to ensure it was made after January 1, 2026.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 39 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2950-2026 (May 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2950-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.