Covidien recalls EndoFLIP 1 System catheters that may be incorrectly flagged as expired after January 1, 2026, risking clinical procedure delays.
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
Covidien is recalling EndoFLIP 1 System catheters that could be incorrectly flagged as expired after January 1, 2026. This may cause delays in clinical procedures if the catheters are used.
The system's 24-hour usage limit causes catheters to be incorrectly flagged as expired after January 1, 2026. This means the catheters may not be available for clinical procedures when needed, potentially delaying treatments.
Healthcare providers using the EndoFLIP 1 System catheters, particularly those in clinical settings that rely on these devices for procedures. Patients receiving procedures using the recalled catheters may be affected.
Check for the EndoFLIP 1 System with model numbers 05391530810050, 10884521809307, or 108884521808096. The catheters were sold after January 1, 2026.
Verify the catheter's production date to ensure it was made after January 1, 2026.
The EndoFLIP System's 24-hour usage limit causes catheters to be incorrectly flagged as expired after January 1, 2026, potentially delaying clinical procedures.
Look for model numbers 05391530810050, 10884521809307, or 10884521808096 on the catheters, which were sold after January 1, 2026.
Check the catheter's production date to ensure it was made after January 1, 2026. If it is, contact the manufacturer for further guidance.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2950-2026 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2950-2026 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
