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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 AK 98 Dialysis Machines Recalled for PCB and PCBA Exposure Risk

Agency Publication Date: November 13, 2024
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Summary

Baxter (now operating as Vantive) is recalling approximately 1,100 AK 98 Dialysis Machines because patients may be exposed to hazardous chemicals known as non-dioxin-like polychlorinated biphenyls (PCBs) and polychlorinated biphenyl acids (PCBAs). This recall specifically targets machines that have been in use for less than 500 hours of runtime. While no injuries have been reported, Baxter is taking this action following similar reports of chemical exposure risks in other dialysis and peritoneal devices from various manufacturers.

Risk

Exposure to PCBs and PCBAs during hemodialysis treatment may pose long-term health risks, including potential toxic effects on the body. No incidents or injuries have been reported to date for the AK 98 machines.

What You Should Do

  1. This recall affects Baxter AK 98 Dialysis Machines (Hemodialysis Delivery System) with Product Code 955607 and UDI/DI 07332414124519.
  2. To determine if your machine is affected, check the total runtime hours on the device display; all serial numbers with less than 500 hours of use are included in this recall.
  3. Stop using the recalled device. Contact Baxter Healthcare Corporation (Vantive) or your medical supply distributor to arrange for a return, replacement, or corrective service.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information 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: Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System
Model / REF:
955607
Serial Numbers:
All serials with runtime less than 500 hours
UDI:
07332414124519

As of February 2025, the firm name is Vantive.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95527
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Medical supply distributors; Hospitals; Dialysis clinics
Manufactured In: United States
Units Affected: 1100 units
Distributed To: Nationwide
Agency Last Updated: March 26, 2026

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.