EndoFLIP recallZ-2950-2026 · Covidien, LLC · initiated May 13, 2026

Why it was recalled

Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures.

FDA root cause category: Under Investigation by firm

What the company is doing

On 05/13/2026, an "URGENT: MEDICAL DEVICE CORRECTION" letter was emailed/mailed to inform customer that EF-100 modules are affected by an end-of-life (EOL) software issue that prevents the units from recognizing Endoflip and Esoflip catheters after 01-January-2026, causing them to appear as expired. On 07/145/2026, an "Update to Urgent: Medical Device Correction" letter was sent via UPS 2-Day delivery updated potential patient harms Customers are instructed that: "May use the EF-300 system, if they have one. It is recommended to consult their biomedical staff for assistance in adjusting the internal clock. Instructions for this process are enclosed with this notification. As the product has reached end-of-life and end-of-service, Medtronic Technical Services is unable to assist in resetting the internal clock. The user is advised that effects of the data change workaround are seen in exported files. When a USB drive is inserted into the EF-100 system, the SAVE button is enabled to record raw data. For each procedure, a folder is generated and is automatically deleted when the next procedure begins. The folder name includes the Patient ID, the date (YYMMDD format), and the time (HH:MM). All files generated within this folder include the Patient ID in their filenames. The live data file contains raw data with time stamps. These timestamps will reflect the system date, which, under the Date Change Workaround, will be set to 2020. "Post this notice in all care environments where the affected products are used, to maintain awareness to this issue. "Share this notice with all relevant personnel within your organization, and with any organization to which the affected product listed in the Product Information table above has been transferred or distributed. "Complete and return the enclosed Customer Confirmation Form to [insert e-mail], even if you do not have any affected product in your inventory, to acknowledge that you have read and understand this letter.

Recall details

Recall number

Z-2950-2026

Status

Open, Classified

Initiated by the company

May 13, 2026

Posted by the FDA

Aug 14, 2026

Recalling firm

Covidien, LLC

Quantity

327

Product code

FFX

FDA submissions

K183072

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.

Product description

EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• EndoFLIP EF-100

  Covidien LP · System, Gastrointestinal Motility (Electrical)
  1 recall0 reports
• Endoflip RFG-EF100

  Covidien LP · SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
  1 recall0 reports

Product lines

• EndoFLIPCovidien LP · 8 models · 40 reports · 1 recall