FDA recall Z-0912-2026

Nipro Medical Corporation · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2025-10-27
Report date
2025-12-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Doral, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0912-2026