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U.S. Department of Health and Human Services

Class 2 Device Recall EndoFLIP System

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 Class 2 Device Recall EndoFLIP Systemsee related information
Date Initiated by FirmMay 13, 2026
Date PostedAugust 14, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2950-2026
Recall Event ID 99176
510(K)NumberK183072 
Product Classification System, gastrointestinal motility (electrical) - Product Code FFX
ProductEndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684
Code Information ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684
FEI Number 3004904811
Recalling Firm/
Manufacturer		 Covidien, LLC
3062 Bunker Hill Ln
Santa Clara CA 95054-1105
For Additional Information ContactSabrina Zimring
508-261-8000
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionOn 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 Commerce327
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FFX
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