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 | There is the potential for missing motor mounting screws, which may have occurred during the servicing process. |
| Product | Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX |
| Quantity | 66 units |
| Distribution | US: Nationwide |
| Initiated | 2025-02-05 |
| Classified | 2025-03-06 |
| Recall number | Z-1253-2025 |
| 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-1253-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96289/
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