Welch Allyn Life2000 Ventilation System — Class I medical device recall Z-0046-2025
Ongoing recall by Baxter Healthcare Corporation, reported 2024-10-30, distributed nationwide. The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 c
| Recall number | Z-0046-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-09-12 |
| Classified | 2024-10-22 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Quantity | 10,957 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00815410020537, 00887761978089 |
| Model numbers | MS-01-0118 |
Product
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
Reason for recall
The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.
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-0046-2025. 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.