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# Fresenius Recalls Some Hemodialysis Machines
- URL: https://www.fdaweb.com/fresenius-recalls-some-hemodialysis-machines/
- Published: 2023-10-24T12:00:00.000Z
- Updated: 2026-09-14T14:14:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155641

Fresenius Medical Care is recalling (Class 1) some of its 2008 series hemodialysis machines because patients may be exposed to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) that leach from some peroxide-cured silicone tubing used in the machines. “Data provided by the manufacturer indicates that the amount of NDL PCBAs decreases over the first month during routine clinical use of the hemodialysis machine,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/fresenius-medical-care-recalls-some-hemodialysis-machines-potential-exposure-toxic-compounds?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. Fresenius is retrofitting affected machines manufactured between 8/21/2008 and 6/6/2022 that contain the suspect silicone tubing, it says.

The notice says that using affected machines may cause serious adverse health consequences months to years after exposure, including [endocrine](https://medlineplus.gov/endocrinesystem.html?ref=fdaweb.com) dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes), and male infertility.