CLASS I ONGOING Device recall · Reported 11 Sep 2024 · FDA Enforcement Report
Vivo 45 LS, pressure and volume ventilator capable recalled
Breas Medical is recalling Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or, distributed nationwide in the US. The recall was initiated on 25 Jul 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2690-2024
- FDA event ID
- 95042
- Recalling firm
- Breas Medical, North Billerica, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 25 Jul 2024
- FDA classified
- 3 Sep 2024
- Reported
- 11 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 25 Jul 2024 | Recall initiated by company | |
| 3 Sep 2024 | Classified by FDA | +40 days |
| 11 Sep 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
Where it was distributed
US Nationwide.
Questions about this recall
Is Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or recalled?
Yes. Breas Medical recalled Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or on 25 Jul 2024. The recall is Class I and its status is Ongoing. Recall number Z-2690-2024.
Why was it recalled?
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.
Which lots are affected?
Model No 230000; UDI-DI 07321822300004; Lot Code: all lots up to 240530.
Where was it sold?
US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Breas Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | with Notch 22M/15F sold as part of Breas Medical MPV recalled | Breas Medical | Other | Nationwide |
| Device | CLASS II | Vivo 45LS Ventilator- intended to provide continuous recalled | Breas Medical | Device Malfunction | Nationwide |
| Device | CLASS II | Breas Ventilator Trolley with the Vivo 50/60/65 recalled | Breas Medical | Other | Nationwide |
| Device | CLASS II | Protective Cover Vivo 55/65 (Used for Vivo 50/65) recalled | Breas Medical | Other | Nationwide |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |