Welch Allyn Life2000 Ventilation system — Class I medical device recall Z-1725-2025
Ongoing recall by Baxter Healthcare Corporation, reported 2025-05-21. A cybersecurity vulnerability was discovered through internal testing.
| Recall number | Z-1725-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2025-04-07 |
| Classified | 2025-05-09 |
| Reported by FDA | 2025-05-21 |
| Quantity | 4,881 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00815410020278, 00815410020537, 00887761978089 |
Product
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.
Reason for recall
A cybersecurity vulnerability was discovered through internal testing.
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-1725-2025. 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.