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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

Baxter SIGMA Spectrum Infusion Pumps Recalled for Incorrect Software Version

Agency Publication Date: July 17, 2025
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Summary

Baxter Healthcare Corporation is recalling 42 Baxter SIGMA Spectrum Infusion Pumps (Model Numbers 35700BAX and 35700BAX2) because they may contain an incorrect version of software. The recall affects 14 units of the V6 model and 28 units of the V8 model. Because this device is used to deliver medications and fluids to patients, a software error could lead to improper pump performance. Consumers and healthcare facilities should stop using the affected devices and contact the manufacturer or their distributor immediately to arrange for a return, replacement, or correction.

Risk

The incorrect software version may cause the infusion pump to operate improperly, which could result in the incorrect delivery of medications or fluids. This poses a critical safety risk that could lead to serious injury or death for patients undergoing treatment.

What You Should Do

  1. This recall affects Baxter SIGMA Spectrum Infusion Pump V6 (Model 35700BAX) and Baxter SIGMA Spectrum Infusion Pump V8 (Model 35700BAX2).
  2. Identify if your device is affected by checking the model number and serial number printed on the device label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately to prevent patient harm.
  4. Contact Baxter Healthcare Corporation or your distributor to arrange for the return, replacement, or correction of the software.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Baxter SIGMA Spectrum Infusion Pump V6
Model / REF:
35700BAX
Serial Numbers:
765100
772744
789742
841197
867753
920606
1024015
770164
788724
793079
842498
918342
962810
1027523
UDI:
00085412091570

Recall #: Z-2095-2025; Quantity: 14 units

Product: Baxter SIGMA Spectrum Infusion Pump V8
Model / REF:
35700BAX2
Serial Numbers:
2006307
2052091
2093765
2095360
2104302
2119236
2141815
2025925
2067699
2094483
2095541
2105238
2119436
2143406
2034297
2074097
2094580
2096351
2105769
2135482
2143684
2051591
2090658
2095202
2096856
2118940
2137976
2156201
UDI:
00085412498683

Recall #: Z-2096-2025; Quantity: 28 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97072
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Baxter Healthcare Corporation
Manufactured In: United States
Units Affected: 2 products (14 units; 28 units)
Distributed To: California, Florida, Illinois, Kansas, Michigan, Mississippi, New York, Ohio, Oklahoma, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.