Reported Aug 26, 2026 · Ongoing · Updated Sep 7, 2026
EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100…
Covidien, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien, LLC · 3062 Bunker Hill Ln · Santa Clara, CA · 95054-1105
Is this the product you have?
- EndoFLIP System that includesENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components
- Lot codes and dates
- ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Catheters used after January 1, 2026.
- Amount recalled
- 327
Where it was sold
Why it was recalled
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
This product could cause temporary or reversible health problems — stop using it.
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