Z-2950-2026Class II

EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM...

Name: Z-2950-2026 EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM...
Creator: Covidien, LLC
Published: 2026-05-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2026-05-13 / Open, Classified

FDA source

Covidien, LLC began a recall of EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL... on 2026-05-13. FDA classified it as Class II and gives the reason as "Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2950-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-13
Posted: 2026-08-14
Recalling firm: Medtronic, Inc.
Product: EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684
Product code: FFX System, Gastrointestinal Motility (Electrical)
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 327
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 codes and lots: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2950-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2950-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14

Product code FFX

K183072Class IIEndoFLIP SystemCrospon, Ltd. / cleared 2019-02-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)