Breathe Technologies — Class I medical device recall Z-0887-2025
Ongoing recall by Baxter Healthcare Corporation, reported 2025-01-22, distributed nationwide. There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the a
| Recall number | Z-0887-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-12-20 |
| Classified | 2025-01-16 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 00815410020537, 00887761978089 |
| Serial numbers | 122010001081 |
| Model numbers | BT-20-0002AP |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0887-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.