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fda_recall · device_recall · high

AVID Medical, Inc. — Class II recall: Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualiz…

Event date
2026-08-26 00:00:00Z
Observed
2026-09-08 04:20:29Z
Source ID
Z-2964-2026
Payload hash
e7bde26f81c29da5bd084f5c

Summary

The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit. Status: Ongoing.

Frequently asked questions

Has AVID Medical, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 27 total FDA actions tied to AVID Medical, Inc.: 0 warning letters, 27 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). AVID Medical, Inc. — Class II recall: Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualiz…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-avid-medical-inc-z-2964-2026
MLA
"AVID Medical, Inc. — Class II recall: Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualiz…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-avid-medical-inc-z-2964-2026.
Chicago
Argus HQ Research. "AVID Medical, Inc. — Class II recall: Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualiz…." Digital Empire Holdings LLC. Accessed September 8, 2026. https://argushq.ai/events/fda-recall-avid-medical-inc-z-2964-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_avid_medical_inc_z_2964_2026_2026,
  title = {AVID Medical, Inc. — Class II recall: Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualiz…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-avid-medical-inc-z-2964-2026},
  note = {Accessed: September 8, 2026}
}

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