FDA Device recall Z-0887-2025
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
- FDA Device
- Class I
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class I recall of Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP by Baxter Healthcare, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0887-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-12-20 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Reason
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.
Identifiers
| code_info | UDI/DI 00887761978089 or 00815410020537, Serial Numbers: 122010001081 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0887-2025%22
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