Baxter SIGMA Spectrum Infusion Pump with Master Drug Library — Class II medical device recall Z-0776-2025
Ongoing recall by Baxter Healthcare Corporation, reported 2025-01-08, distributed nationwide. Devices were identified as released after repair without full testing being performed, which includes flow tes
| Recall number | Z-0776-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-11-19 |
| Classified | 2024-12-27 |
| Reported by FDA | 2025-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 00085412498683 |
| Serial numbers | 2153638 |
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Reason for recall
Devices were identified as released after repair without full testing being performed, which includes flow 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-0776-2025. 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.