FDA Medical devices recall ·
Breathe Technologies, Inc., Life2000 Ventilation System recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0887-2025
- Date
- (initiated December 20, 2024)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 1 unit
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 00887761978089 or 00815410020537, Serial Numbers: 122010001081
Distribution
US, Nationwide Distribution
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0887-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.