Class I U.S. Food and Drug Administration

Ventec Life Systems, Inc. VOCSN V+Pro package, REF: PRT-01198-000 recall: Respiratory system intended to provide continuous/intermittent ventilator

Recall published 6 months ago

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

The hazard: Lead or heavy metal content

The recall is about heavy metal content exceeding what U.S. law allows in a product children handle.

What the notice says: 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

Why it matters: The product exceeds the federal limit on lead or another heavy metal. Lead harms the developing brain, and the damage builds quietly from small repeated exposures rather than arriving as a single dramatic poisoning.

Symptoms and when to call a doctor

The CDC states there is no known safe level of lead in a child’s blood, and that most children with elevated levels show no symptoms at all. That is why a blood lead test, not a symptom check, is the way to find out. Ask your paediatrician about testing if a child has handled, mouthed or worn the product regularly. Where symptoms do appear they are non-specific — irritability, poor appetite, stomach pain, tiredness, constipation or a drop in attention and learning.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1942-2026
Published
May 13, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Ventec Life Systems, Inc.
Product type
Medical devices
Units affected
42
Distribution
California, Georgia, Missouri, Ohio
Made in
United States
Lot / code info
UDI-DI (REF/UDI-DI): PRT-01198-000/00855573007914, PRT-01185-000/00855573007877 Package/Device Serial Number (package serial number may include a "P" at the end): 152884, 152885, 152886, 152887, 152888, 152889, 152890, 152891, 152892, 152893, 152895, 152896, 152897, 152898, 152899, 152900, 152901, 152902, 152903, 152904, 152908, 152909, 152910, 152911, 152912, 152913, 152914, 152915, 152916, 152917, 152918, 152919, 152986, 152987, 155236, 156507, 156512, 156515, 156516, 156517, 156524, 156532
UPC codes
00855573007914, 00855573007877

Products covered by this recall

VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00855573007914
  • 00855573007877

Model or item number

On the rating label, the box or the instruction sheet.

  • PRT-01198-000
  • PRT-01185-000 — UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Lead

Ventec Life Systems, Inc. — The recall is about heavy metal content exceeding what U.S. law allows in a product children handle.

  1. Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.
  2. Wash the hands of anyone who has been handling it, and wipe down the surfaces it has been sitting on.
  3. Ask your paediatrician whether a blood lead test is warranted, especially for a child under six or anyone pregnant.
  4. Do not sand, scrape, burn or break the item up; that turns a contained hazard into dust you can breathe.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.
  • Give it ten working days, then chase in writing and quote your claim reference.

Company contact: Ventec Life Systems, Inc. — 22002 26th Ave Se, Bothell, WA, 98021-4903

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Ventec Life Systems, Inc. medical devices recalled?

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 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00855573007914, 00855573007877; model number PRT-01198-000, PRT-01185-000 — UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Which states were affected?

The notice lists California, Georgia, Missouri, Ohio.

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