Medical device recalls Moderate risk

Nipro Medical Corporation recalls Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only

Recall date
October 27, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0912-2026
FDA classification
Class II
Brand / firm
Nipro Medical Corporation
Sold / distributed
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.

Why it was recalled

Screw may loosen or fallout of Hemodialysis system

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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