Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
FDA Recall Z-0912-2026 · Posted 2025-12-11
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Recalling FirmNipro Medical Corporation
Recall StatusOpen, Classified
Product CodeKDI
Date Initiated2025-10-27
Reason for Recall
Screw may loosen or fallout of Hemodialysis system
Firm Action
On October 27, 2025, Nipro issued a voluntary recall notification to affected consignees via E-Mail. In addition to provide information on the recall, Nipro asked consignees to take the following actions:
1. Please complete the enclosed SURDIAL DX Hemodialysis System Response Form to ensure the correct contact information for each machine to enable timely service appointments.
2. Pass this notice on to any facility that the Surdial DX Hemodialyis system has been transferred to.
3. Ensure all operators are aware of this recall notification.
4. Maintain a copy of the notification with affected machines.
5. Before each use, verify that the blood pump rotor assembly is securely fastened and operates smoothly without unusual vibration or looseness.
6. Monitor all impacted SURDIAL DX machines during operation for abnormal / unusual sounds, vibration or system error messages associated with the blood pump rotor assembly.
7. If any abnormality occurs, discontinue use immediately, safely remove the patient from the system following your facility protocols as appropriate.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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