What should someone who has this product do?

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Check the product against FDA's description (VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000) and recall number Z-1942-2026, then follow Ventec Life Systems, Inc.'s recall instructions.

Has Ventec Life Systems, Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 2 total FDA actions tied to Ventec Life Systems, Inc., including 2 recalls and 0 warning letters.

Recall Record: Class I Recall: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit,… by Ventec Life Systems, Inc.

Here's the summary: Ventec Life Systems, Inc. recalled VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 on 2026-05-13. FDA classified this action as a Class I recall (recall number Z-1942-2026). Reason for recall: 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 delivery prior to (additional items listed in FDA's full record). Recall status: Ongoing. This is a device-category FDA recall record.

Key facts

Recalling firm	Ventec Life Systems, Inc.
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Classification	Class I
Recall number	Z-1942-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	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 delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk

What consumers should do

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 -- and the recall number Z-1942-2026. If it matches, stop using or distributing it and contact Ventec Life Systems, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is Ventec Life Systems, Inc. and the affected product is described in FDA's record as: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000. FDA's stated reason for the recall is: 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 delivery prior to (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-1942-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

Ventec Life Systems, Inc.’s FDA history

Argus HQ has recorded 2 total FDA actions tied to Ventec Life Systems, Inc.: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?: Ventec Life Systems, Inc. recalled VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000. FDA's record states the reason for recall as: 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 delivery prior to (additional items listed in FDA's full record). The recall is logged under FDA recall number Z-1942-2026 with.
How serious is this recall?: FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification.
What should someone who has this product do?: Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Check the product against FDA's description (VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000) and recall number Z-1942-2026, then follow Ventec Life Systems, Inc.'s recall instructions.
Has Ventec Life Systems, Inc. had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 2 total FDA actions tied to Ventec Life Systems, Inc., including 2 recalls and 0 warning letters.

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Full FDA history for Ventec Life Systems, Inc.

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). Recall Record: Class I Recall: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit,… by Ventec Life Systems, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-ventec-life-systems-inc-z-1942-2026

MLA

"Recall Record: Class I Recall: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit,… by Ventec Life Systems, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-ventec-life-systems-inc-z-1942-2026.

Chicago

Argus HQ Research. "Recall Record: Class I Recall: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit,… by Ventec Life Systems, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-ventec-life-systems-inc-z-1942-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_ventec_life_systems_inc_z_1942_2026_2026,
  title = {Recall Record: Class I Recall: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit,… by Ventec Life Systems, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-ventec-life-systems-inc-z-1942-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗