Nipro Medical Corporation: Device Recall
Recall #Z-0912-2026 · 10/27/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0912-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Nipro Medical Corporation
- Status
- Ongoing
- Date Initiated
- 10/27/2025
- Location
- Doral, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Reason for Recall
Screw may loosen or fallout of Hemodialysis system
Product Description
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.