Baxter SIGMA Spectrum Infusion Pump — Class II medical device recall Z-2530-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-08-14, distributed nationwide. Improperly performed testing prior to release
| Recall number | Z-2530-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-06-14 |
| Classified | 2024-08-07 |
| Reported by FDA | 2024-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| Serial numbers | 2158913 |
Product
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Reason for recall
Improperly performed testing prior to release
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-2530-2024. 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.