CLASS I ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Breathe Technologies, Inc., Life2000 Ventilation System recalled
Baxter Healthcare is recalling Breathe Technologies, Inc., Life2000 Ventilation System, distributed nationwide in the US. The recall was initiated on 20 Dec 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-0887-2025
- FDA event ID
- 95842
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 20 Dec 2024
- FDA classified
- 16 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 20 Dec 2024 | Recall initiated by company | |
| 16 Jan 2025 | Classified by FDA | +27 days |
| 22 Jan 2025 | Published in enforcement report | +6 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 an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Where it was distributed
US, Nationwide Distribution
Questions about this recall
Why was it recalled?
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Which lots are affected?
UDI/DI 00887761978089 or 00815410020537, Serial Numbers: 122010001081
Where was it sold?
US, Nationwide Distribution
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 95842This product is part of a recall event; the main page for the event is Welch Allyn, Inc., Life 2000 Ventilation System recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Welch Allyn, Inc., Life 2000 Ventilation System recalled | Baxter Healthcare | Device Malfunction | Nationwide | |
| CLASS I | Welch Allyn, Inc., Life2000 Ventilation System recalled | Baxter Healthcare | Device Malfunction | Nationwide | |
| CLASS I | Welch Allyn, Inc., Life2000 Ventilation System recalled | Baxter Healthcare | Device Malfunction | Nationwide |
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