Class I — Baxter Healthcare Corporation
| Recalling firm | BAXTER HEALTHCARE CORPORATION |
|---|---|
| Registered facility | View this company's 32 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Certain Spectrum infusion pumps may have an incorrect version of software. |
| Product | Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX |
| Quantity | 14 units |
| Distribution | US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA. |
| Initiated | 2025-06-20 |
| Classified | 2025-07-17 |
| Recall number | Z-2095-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Baxter Healthcare Corporation (Z-2095-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97072/
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