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MEDICAL DEVICE RECALLMODERATE
EndoFLIP 1 System
Covidien recalls EndoFLIP 1 System due to 24-hour limit flagging products as expired.
What to do
Stop using the affected EndoFLIP 1 System and contact Covidien for instructions on returning the device or obtaining a replacement.
Why it was recalled
Covidien is recalling the EndoFLIP 1 System (EF-100) because the system's 24-hour usage limit incorrectly flags products as expired, rendering them unavailable for clinical procedures.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UDI-DI |
|---|---|
| EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components. | 05391530810050, 10884521809307, 10884521808096, 05391530810166, 10884521786684 |
| EndoFLIP System that includes | – |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Editorial summary by Recall Canary · summary updated 2026-08-21 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification