Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) due to potential flow testing issues after repair. Affected units may have safety risks.
Devices were identified as released after repair without full testing being performed, which includes flow testing.
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📍Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
✎ GovInfoNow plain-language explainer
Baxter is recalling certain SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) because they were released after repair without full testing, including flow testing. This could lead to improper medication delivery if the pump malfunctions. Read more at govinfonow.com/recall/53464-baxter-sigma-spectrum-infusion-pump-recall-flow-testing-risk.
“Baxter SIGMA Spectrum Infusion Pump Recall: Flow Testing Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53464-baxter-sigma-spectrum-infusion-pump-recall-flow-testing-risk. Based on FDA recall #Z-0776-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0776-2025%22&limit=1).
Baxter Healthcare Corporation voluntarily recalled one Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2, because devices were released after repair without full testing including flow testing, the FDA said on Nov. 19, 2024.
How to tell if you have it
Brand: Baxter
Product: SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Product Code: 35700BAX2
UPC: 00085412498683
Serial Number: 2153638
Quantity: 1 unit
The hazard
The FDA said the hazard is that devices were identified as released after repair without full testing being performed, which includes flow testing.
Context
GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since Sept. 2, 2015. Other recent recalls of similar products include Fresenius Kabi LVP-0004 Infusion Pump Recall (Feb. 4, 2026), Boston Scientific Intera 3000 Hepatic Artery Pump Recall (May 11, 2026) and Fresenius Kabi Ivenix Infusion Pump Recall (Nov. 3, 2025).
How to tell if you have this one
Check for the product code 35700BAX2 on the pump. The pump has a Master Drug Library (Version 8) and serial number starting with 2153638.
Brand
Baxter
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of AL, IN.
Recall number
Product, codes & lots
Quantity
Z-0775-2025
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX; GTIN 00085412091570; Serial Number: 779515
1 units
Z-0776-2025
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2; GTIN 00085412498683; Serial Number: 2153638
1 unit
Based on the official FDA remedy
What to do — step by step
Check Pump Details
Look for the product code 35700BAX2 and serial number starting with 2153638 on the pump.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, IN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Indiana.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0776-2025 (November 19, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0776-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.