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fda_recall · device_recall · critical

Ventec Life Systems, Inc. — Class I recall: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

Event date
2026-05-13 00:00:00Z
Observed
2026-07-09 22:52:36Z
Source ID
Z-1942-2026
Payload hash
fd73a4381763a28353362b6f…

Summary

Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen… Status: Ongoing.

Frequently asked questions

Has Ventec Life Systems, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 5 total FDA actions tied to Ventec Life Systems, Inc.: 0 warning letters, 5 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 critical severity by Argus HQ. FDA published the underlying record on 2026-05-13; Argus observed and indexed it on 2026-07-09.
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). Ventec Life Systems, Inc. — Class I recall: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-ventec-life-systems-inc-z-1942-2026
MLA
"Ventec Life Systems, Inc. — Class I recall: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-ventec-life-systems-inc-z-1942-2026.
Chicago
Argus HQ Research. "Ventec Life Systems, Inc. — Class I recall: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000." Digital Empire Holdings LLC. Accessed October 6, 2026. https://argushq.ai/events/fda-recall-ventec-life-systems-inc-z-1942-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_ventec_life_systems_inc_z_1942_2026_2026,
  title = {Ventec Life Systems, Inc. — Class I recall: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-ventec-life-systems-inc-z-1942-2026},
  note = {Accessed: October 6, 2026}
}

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