Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog… — Class II medical device recall Z-1368-2026
Ongoing recall by Baxter Healthcare Corporation, reported 2026-02-25, distributed in OH. Pumps were released without full testing being performed, including occlusion alarm testing.
| Recall number | Z-1368-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2026-01-13 |
| Classified | 2026-02-13 |
| Reported by FDA | 2026-02-25 |
| Distributed | OH |
| Quantity | 5 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00085412610900 |
| Serial numbers | 3815663, 3823468, 3824743, 3825234, 3825599 |
| Model numbers | 3570009 |
Product
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
Reason for recall
Pumps were released without full testing being performed, including occlusion alarm 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-1368-2026. 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.