Class II

Medical Device Recall: Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only

Nipro Medical Corporation · October 27, 2025

Reason for Recall

Screw may loosen or fallout of Hemodialysis system

Distribution

US Nationwide distribution in the states of AL, AR, CA, FL, GA, IL, IA, MI, MN, MS, NJ, NY, NC, ND, OH, OR, PA, SC, SD, TX, WV, WC.

States Affected

NATIONWIDE

Quantity Affected

N/A

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0912-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Nipro Medical Corporation Medical Device Recall: Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only | SafeCheck