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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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Medium RiskFDA Device
Medical Devices

Baxter SIGMA Spectrum Infusion Pumps Recalled for Defective Gear Grease

Agency Publication Date: January 16, 2026
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Summary

Baxter Healthcare Corporation is recalling 585 units of the SIGMA Spectrum Infusion Pump (Model 35700BAX2) due to the use of defective, low-viscosity grease on the internal cam and motor gears. This improper lubrication can cause the pump's mechanism to wear down prematurely, potentially leading to the device delivering too much medication or allowing fluids to flow freely into the patient without control. If you manage or use these specific infusion pumps, you should stop using them and contact the manufacturer or your distributor to arrange for a return, replacement, or correction of the device.

Risk

The defective grease leads to insufficient lubrication of the pump's internal mechanism, causing parts to wear out faster than expected. This can result in the pump failing to control fluid delivery, potentially leading to over-infusion or a free-flow situation that can cause serious injury or death from incorrect dosing.

What You Should Do

  1. The recalled products are SIGMA Spectrum Infusion Pumps, Model/Catalog Number: 35700BAX2, with GTIN 00085412498683.
  2. Identify your pump by checking the model number and serial number on the device label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact Baxter Healthcare Corporation or your authorized distributor to arrange for the return, replacement, or corrective servicing of the affected equipment.
  5. Call the FDA Consumer Complaint hotline at 1-888-INFO-FDA (1-888-463-6332) for additional questions regarding medical device recalls.

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: SIGMA Spectrum Infusion Pump
Model / REF:
35700BAX2
Serial Numbers (585):
2119054
2135735
2132190
2154666
2154656
2096922
2107882
2115820
2116236
2123750
2124467
2142165
2145693
2146570
2135601
2150159
2019614
2030571
2064474
2065875
2007842
2077077
2110000
2139163
2152387
2090011
2150576
2006741
2090877
2091360
2115605
2136756
2145367
2145911
2144366
2147107
2005818
2036444
2040404
2064488
2054317
2064576
2065380
2064711
2055127
2066486
2065852
2065982
2041955
2081026
GTIN:
00085412498683

Units have potentially been released with defective low-viscosity grease applied to mechanism gears.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98167
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Baxter Healthcare Corporation; authorized medical equipment distributors
Manufactured In: United States
Units Affected: 585 units
Distributed To: Nationwide

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.