Use cautionMedical device recall · FDA · Published November 28, 2025
Baxter SIGMA Spectrum Infusion Pump Model 35700BAX2: Defective Grease Risk
Baxter recalls SIGMA Spectrum Infusion Pump Model 35700BAX2 with defective grease that may cause pump failure. Affected units have serial numbers listed in the recall notice.
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
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Contact the company
📍Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
“Baxter SIGMA Spectrum Infusion Pump Model 35700BAX2: Defective Grease Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50579-baxter-sigma-spectrum-infusion-pump-model-35700bax2-defective-grease-risk. Based on FDA recall #Z-1121-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1121-2026%22&limit=1).
Baxter Healthcare Corporation recalled SIGMA Spectrum Infusion Pumps due to a defect that could cause over-infusion or free-flow, the FDA said on Nov. 28, 2025. The recall involves 585 units distributed nationwide.
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to insufficient lubrication on the cam, which could result in premature wear of the mechanism assembly, leading to over-infusion or a free-flow situation.
Context
GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since Sept. 2, 2015. Other recent recalls include PRO+ MRS SURFACE FOR VERSACARE (Aug. 18, 2026), 0.9% Sodium Chloride Injection (Aug. 17, 2026), and Dextrose 2000mL Bags (Aug. 17, 2026). Other recent recalls of similar products include Fresenius Kabi LVP-0004 Infusion Pump (Feb. 4, 2026), Boston Scientific Intera 3000 Hepatic Artery Pump (May 11, 2026), and Philips Integris-Allura System (April 28, 2026).
How to tell if you have this one
Check if your pump has the model number 35700BAX2 and the serial numbers listed in the recall notice. The GTIN is 00085412498683.
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-1121-2026 (November 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1121-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.