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FDA-Device2025-12-17Class IIPROCESSING DEFECT

Nipro Surdial DX hemodialysis system recalled for loose or falling screw

Nipro
OTHERNationwide distribution

Check your Nipro Surdial DX hemodialysis system

A screw in certain Nipro Surdial DX hemodialysis systems may loosen or fall out during use. This is a medical device used in dialysis treatment. The affected units have specific serial numbers issued between 2020 and 2024.

  • If you use a Nipro Surdial DX system, check your serial number against the recall list
  • Contact your dialysis center or healthcare provider immediately if your unit is affected
  • Do not use the device if the screw is loose or missing
  • Ask your provider about a replacement or repair
Hazard

Screw may loosen or fallout of Hemodialysis system

Sold states
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.
Affected count
N/A
Manufactured in
3150 NW 107th Ave, N/A, Doral, FL, United States
Products
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only

Official notice

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

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