FDA-Device2025-12-17Class IIPROCESSING DEFECT
Nipro Surdial DX hemodialysis system recalled for loose or falling screw
What this means
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
The agency's original wording
Hazard
Screw may loosen or fallout of Hemodialysis system
Intended for
Adults
Illnesses reported
None reported
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-0912-2026Want us to check the next one for you?
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