The Recall Desk
HighFDA (Devices)·Z-0327-2025·Announced 2024-11-20

Baxter AK 98 Dialysis Machine Recalled for Potential Chemical Exposure

Baxter is recalling AK 98 Dialysis Machines due to potential exposure to polychlorinated biphenyl acids and polychlorinated biphenyls.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (dialysis machine) where injury has not yet been reported, and the hazard involves potential chemical exposure (PCBs/PCBAs) without confirmed illness, fitting the 'High' severity criteria.

Plain-English summary

Baxter Healthcare Corporation is recalling the AK 98 Dialysis Machine, Hemodialysis Delivery System (Product Code 955607). The recall involves 1,100 units with UDI/DI 07332414124519 and serials with a runtime of less than 500 hours. These units were distributed nationwide in the US and worldwide.

The recall is being conducted because Baxter is aware of recalls by other manufacturers related to 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. The source text does not specify if illnesses or injuries have been reported for this specific product.

Consumers and healthcare providers should contact Baxter Healthcare Corporation for further instructions on how to handle the recalled equipment. As of February 2025, the firm name is Vantive.

The recalled product

Product
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
Affected units
1,100

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 07332414124519
  • All serials with runtime less than 500 hours

Distribution

Distributed nationwide across the United States.