FDA recall Z-0887-2025

Product

Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP

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.

Distribution

US, Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2024-12-20

Report date

2025-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0887-2025