Recall archive / FDA company announcement
Breas: Vivo 45 LS (US Version) Ventilator — FDA announcement Aug 9, 2024
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Aug 9, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Vivo 45 LS (US Version) Ventilator
- Reason
- Potential for short term elevated levels of formaldehyde exposure
- Classification
- Not supplied
- Recalling firm
- Breas Medical
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- a088db4e7304407c
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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) |
Match all identifying details in the current notice. A brand name alone is not enough.
Product tables from the announcement
These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.
| 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) |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Aug 9, 2024
- Company announcement date
- Aug 9, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.