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Lower risk Medical device recall · FDA · Published October 16, 2024

Baxter AK 98 Dialysis Machine Recall: PCB Exposure Risk

Baxter recalls AK 98 Dialysis Machines with specific serial numbers due to potential exposure to PCBs during use. Affected units have runtime under 500 hours.

🇺🇸 FDA recall #Z-0327-2025Medical deviceBaxter ›
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Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
✎ GovInfoNow plain-language explainer

Baxter is recalling AK 98 Dialysis Machines with serial numbers and runtime under 500 hours because they may expose users to PCBs. This could pose health risks during dialysis treatment. Read more at govinfonow.com/recall/53698-baxter-ak-98-dialysis-machine-recall-pcb-exposure-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/53698-baxter-ak-98-dialysis-machine-recall-pcb-exposure-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0327-2025

Cite this page

“Baxter AK 98 Dialysis Machine Recall: PCB Exposure Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53698-baxter-ak-98-dialysis-machine-recall-pcb-exposure-risk. Based on FDA recall #Z-0327-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0327-2025%22&limit=1).

Baxter Healthcare Corporation recalled the Baxter AK 98 Dialysis Machine and Hemodialysis Delivery System due to potential exposure to non-dioxin-like polychlorinated biphenyl acids and polychlorinated biphenyls, according to the FDA. The agency announced the voluntary Class I recall on Oct. 16, 2024. Owners should contact Baxter for details.

How to tell if you have it

  • Brand: Baxter
  • Product: AK 98 Dialysis Machine, Hemodialysis Delivery System
  • Product Code: 955607
  • UDI/DI: 07332414124519
  • Condition: All serials with runtime less than 500 hours
  • Quantity: 1,100 units

The hazard

The recall addresses the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices, according to the FDA. Baxter is aware of several recalls by other manufacturers related to this risk.

Context

GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since Sept. 2, 2015. Other recent recalls include a PRO+ 36" MRS SURFACE mattress recall (Aug. 18, 2026), a 0.9% Sodium Chloride Injection recall for fiberglass particulates (Aug. 17, 2026), and a Dextrose 2000mL Bags recall for stainless steel particles (Aug. 17, 2026). Other recent recalls of similar products include a Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set recall for blood leak risk (Aug. 10, 2026), a Nipro MedicaLyte Bicarbonate Concentrate recall for high endotoxin risk (Aug. 5, 2026), and Bard Power-Trialysis Dialysis Catheters downstream recall for safety (Aug. 10, 2026).

How to tell if you have this one

Check for serial numbers starting with UDI/DI 07332414124519 and runtime under 500 hours. The product code is 955607.

  • Brand
    Baxter
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Machine Serial

    Look for the serial number starting with UDI/DI 07332414124519 and ensure runtime is under 500 hours.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution and worldwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 35 days after the firm started it.

1. Firm started the recall: Oct 16, 202412. FDA classified it Class I: Nov 13, 202423. Published in FDA’s Enforcement Report: Nov 20, 202432024
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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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-0327-2025 (October 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0327-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA