Elevated risk U.S. Food and Drug Administration

Breas Vivo 45 LS Ventilator recall: Potential for short term elevated levels of formaldehyde exposure

Recall published 2+ years ago

Potential for short term elevated levels of formaldehyde exposure

The hazard: Harmful chemical exposure

A chemical contaminant is behind this recall. The official notice names the substance, and that name is what a clinician or Poison Control will want to hear.

What the notice says: Short term formaldehyde emissions may lead to adverse pulmonary or neurological effects such as the potential for transient, reversible airway irritation or inflammation that could lead to airway hyperresponsiveness such as asthma in small pediatric patients resulting in additional medical intervention (e.g., bronchodilator administration, adjustment of ventilator settings, increased duration or degree of ventilatory support and/or oxygen support).

Why it matters: A chemical that should not be present at this level was found in the product. Depending on the substance, the concern may be a burn or irritation on contact, or a long-term risk from repeated exposure.

Symptoms and when to call a doctor

For a splash or spill, rinse the skin or eyes with running water for 15 to 20 minutes and remove contaminated clothing. If the product was swallowed, or if there is any trouble breathing, call Poison Control on 1-800-222-1222, which operates free and around the clock — or 911 if the person is collapsing, struggling to breathe or unconscious. Take the container or a photo of the label with you to any appointment.

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

Published
August 9, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Breas
Product type
Medical devices
Distribution
Nationwide

Products covered by this recall

Vivo 45 LS (US Version) Ventilator

What the company announced

On August 5, 2024, Breas Medical initiated a U.S. nationwide correction of 8,186 Vivo 45 LS ventilator devices. Internal testing of the ventilator identified the potential for short term elevated levels of formaldehyde exposure to users under specific conditions. Short term formaldehyde emissions may lead to adverse pulmonary or neurological effects such as the potential for transient, reversible airway irritation or inflammation that could lead to airway hyperresponsiveness such as asthma in small pediatric patients resulting in additional medical intervention (e.g., bronchodilator administration, adjustment of ventilator settings, increased duration or degree of ventilatory support and/or oxygen support).

The devices subject to this correction were manufactured from February 4, 2021 to July 1, 2024, and distributed from February 12, 2021 to July 24, 2024.

Breas Medical has not received any reports of patient injury or adverse effects related to potential exposure to formaldehyde from the use of the Vivo 45 LS, to date.

The devices in the table below are subject to this correction. The devices in the table can be identified by the model name on the front panel of the device and the model and serial numbers on the back panel (“REF” and “SN”, respectively). The devices have been distributed nationwide in the U.S. to Durable Medical Equipment providers (“DME’s”), distributors, and facilities.

  • Affected Product Information Table: Model name · Model number · UDI-DI · D*****, F*****, K*****, M*****, N01*** - N270030 Manufacturing dates up to and including “240530” (May 30th, 2024)

Breas Medical is notifying its distributors and commercial customers in the U.S. by email and phone of the correction. The correction reduces the maximum room air temperature for operation of the device from 40°C (104°F) to 30°C (86°F) and requires new devices shipped through July 24, 2024, to be pre-run for 14 days prior to patient use.

Existing end users in the U.S. will receive an update to the Instructions for Use (IFU) as the correction.

End users and other recipients of the Vivo 45 LS device in the U.S. should contact the company that provided the device or Breas Medical for further information regarding the necessary corrective measures if needed.

Patients, caregivers and other users of the Vivo 45 LS device with questions may contact the Breas Medical via telephone at 1-855-436-8724 Monday through Friday between the hours of 8.00 am and 5.00 pm (Eastern time zone). You may also contact the company via e-mail at [email protected]

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Breas Medical has notified FDA of this voluntary U.S. nationwide correction.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Establishment number

Inside the USDA mark of inspection on the label.

  • 240530

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

What to do about Chemical

Breas — A chemical contaminant is behind this recall. The official notice names the substance, and that name is what a clinician or Poison Control will want to hear.

  1. Stop using the product and keep it away from children and pets.
  2. Do not pour it down a drain or into a bin without checking local hazardous-waste rules, and never mix it with another cleaner.
  3. Ventilate the room if the product was sprayed or applied there.
  4. Keep the container — the lot code on it is what a refund claim and any medical follow-up both depend on.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • If the company stops responding, escalate to the CPSC. Firms under a recall order have reporting duties to the agency.
  • Have the model number, the date code and your photos ready. Many companies issue store credit by default — ask for cash or a card reversal if you would rather have it.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.

Company contact: Breas Medical — Consumers: Breas Medical,, 1-855-436-8724, [email protected]

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 — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Breas medical devices recalled?

Potential for short term elevated levels of formaldehyde exposure Short term formaldehyde emissions may lead to adverse pulmonary or neurological effects such as the potential for transient, reversible airway irritation or inflammation that could lead to airway hyperresponsiveness such as asthma in small pediatric patients resulting in additional medical intervention (e.g., bronchodilator administration, adjustment of ventilator settings, increased duration or degree of ventilatory support and/or oxygen support).

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: establishment number 240530. 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?

Stop using the product and keep it away from children and pets.

Can I get my money back?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

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