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fda_recall · device_recall · high

Covidien, LLC — Class II recall: EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 108845…

Event date
2026-08-26 00:00:00Z
Observed
2026-09-08 04:20:31Z
Source ID
Z-2950-2026
Payload hash
b09df6e0400eb754b2ed9b39…

Summary

The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures. Status: Ongoing.

Entities

View source record ↗

Frequently asked questions

Has Covidien LLC had other FDA enforcement actions?
Yes. Argus HQ has recorded 6 total FDA actions tied to Covidien LLC: 0 warning letters, 6 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-08-26; Argus observed and indexed it on 2026-09-08.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2026). Covidien, LLC — Class II recall: EndoFLIP System that includes:  ENDOFLIP 1 SYSTEM EF-100  05391530810050  108845…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-covidien-llc-z-2950-2026
MLA
"Covidien, LLC — Class II recall: EndoFLIP System that includes:  ENDOFLIP 1 SYSTEM EF-100  05391530810050  108845…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-covidien-llc-z-2950-2026.
Chicago
Argus HQ Research. "Covidien, LLC — Class II recall: EndoFLIP System that includes:  ENDOFLIP 1 SYSTEM EF-100  05391530810050  108845…." Digital Empire Holdings LLC. Accessed September 8, 2026. https://argushq.ai/events/fda-recall-covidien-llc-z-2950-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_covidien_llc_z_2950_2026_2026,
  title = {Covidien, LLC — Class II recall: EndoFLIP System that includes:  ENDOFLIP 1 SYSTEM EF-100  05391530810050  108845…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-covidien-llc-z-2950-2026},
  note = {Accessed: September 8, 2026}
}

Informational only. Not legal, financial, or medical advice.

Covidien, LLC — Class II recall: EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 108845… · Argus HQ