Baxter SIGMA Spectrum Infusion Pump Recall: Improper Testing Risk
Baxter recalls SIGMA Spectrum Infusion Pumps with product code 3570: improper testing before release may cause safety issues. Affected units have serial number 2158913.
Recall notice
Improperly performed testing prior to release
Contact the company
What happened, in plain English
Baxter is recalling SIGMA Spectrum Infusion Pumps with product code 35700BAX2 due to improper testing before release. This could lead to safety risks if the pump is used without proper validation. Read more at govinfonow.com/recall/54844-baxter-sigma-spectrum-infusion-pump-recall-improper-testing-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/54844-baxter-sigma-spectrum-infusion-pump-recall-improper-testing-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2530-2024
Cite this page
“Baxter SIGMA Spectrum Infusion Pump Recall: Improper Testing Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54844-baxter-sigma-spectrum-infusion-pump-recall-improper-testing-risk. Based on FDA recall #Z-2530-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2530-2024%22&limit=1).
Why it’s dangerous
The pump was released without proper testing, which could lead to safety issues if used without validation. This might cause improper medication delivery or other complications during medical treatment.
Who’s affected
Patients using the Baxter SIGMA Spectrum Infusion Pump with product code 35700BAX2 and serial number 2158913 are affected. Healthcare providers and patients using this specific model are at risk.
How to tell if you have this one
Check for product code 35700BAX2 and serial number 2158913 on the pump. This model was sold by Baxter Healthcare Corporation.
- Brand
Baxter- Category
Medical device
What to do — step by step
Check Product Details
Identify the product code and serial number on your pump to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of Florida.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this pump dangerous to use?
The recall states improper testing before release, but the specific danger is not detailed in the official notice.
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Where this comes from
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-2530-2024 (June 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2530-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.