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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 and Spectrum IQ Infusion Systems Recalled for Missing Screws

Agency Publication Date: March 6, 2025
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Summary

Baxter Healthcare Corporation has recalled 389 units of its Sigma Spectrum (V6 Platform) and Spectrum IQ Infusion Systems because they may be missing motor mounting screws. This defect likely occurred during the device servicing process. No injuries or incidents related to this issue have been reported at this time.

Risk

Missing mounting screws can cause the motor within the infusion system to shift or fail. This could lead to an interruption or total failure in the delivery of life-sustaining medications or fluids, potentially causing serious health complications for patients.

What You Should Do

  1. The recalled products are Baxter Sigma Spectrum Infusion Systems (Product Code 35700BAX) and Baxter Spectrum IQ Infusion Systems with Dose IQ Safety Software (Product Code 3570009).
  2. To identify if your specific device is included in this recall, locate the product code and serial number on the manufacturer's label attached to the device. 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 medical device distributor to arrange for the return, replacement, or correction of the affected equipment.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information or to report a problem.

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 System (V6 Platform)
Model / REF:
35700BAX
Serial Numbers (66):
704198
728888
751492
758399
758614
761662
763197
766291
772611
773302
775486
778837
785425
793453
795240
798065
814485
818850
826637
850214
850854
851500
854157
855803
863354
870307
873114
876483
877014
877102
889153
896292
900181
906422
907176
912242
913562
927864
938265
958176
962828
963975
965158
974676
981605
982459
984154
986132
986634
989053
UDI:
00085412091570

Recall #: Z-1253-2025

Product: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software
Model / REF:
3570009
Serial Numbers (323):
3020290
3020992
3020996
3021929
3023080
3023183
3023537
3023758
3500529
3502799
3502864
3510806
3511639
3512647
3514801
3516888
3517399
3517517
3518558
3519053
3564064
3564818
3565462
3565620
3566022
3566254
3567145
3567218
3567998
3568527
3568922
3570910
3571100
3571598
3571972
3573147
3573504
3574293
3575033
3575107
3576026
3576443
3656732
3657316
3657541
3657814
3657821
3657995
3659259
3660176
UDI:
00085412610900

Recall #: Z-1254-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96289
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: authorized medical device distributors; hospital supply networks
Manufactured In: United States
Units Affected: 2 products (66 units; 323 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.