Breas Medical recalls Vivo 45 LS ventilators with potential formaldehyde emissions in specific conditions. Affected units have model numbers 230000 (230016, 230216) and were sold up to May 2024.
There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
Breas Medical is recalling Vivo 45 LS ventilators that may emit elevated formaldehyde levels in specific conditions. This could pose a health risk to patients breathing the air through the device.
The ventilator may release formaldehyde into the patient's breathing airpath under certain conditions. This could lead to short-term elevated formaldehyde levels in the air the patient breathes.
Patients using the Vivo 45 LS ventilator for mechanical ventilation are most at risk. The recall applies to specific model numbers and production lots.
Check for model numbers 230000 (230016, 230216) on the ventilator. The device was sold with lot codes up to 240530 (May 2024).
Look for model numbers 230000 (230016, 230216) on the ventilator.
The ventilator may emit elevated formaldehyde levels in specific conditions, so it is not safe to use without checking the recall.
Check for model numbers 230000 (230016, 230216) and lot codes up to 240530 (May 2024).
The recall does not specify a remedy, so contact Breas Medical for guidance.
We’ve drafted a message you can send Breas Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2690-2024 — Breas Medical Breas Medical Hello, I own a Breas Medical that is covered by recall Z-2690-2024 from Breas Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
