Recall Z-0912-2026 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Nipro Medical Corporation
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
| Date | Dec 11, 2025 (initiated Oct 27, 2025) |
| Status | Open, Classified |
| Reason | Screw may loosen or fallout of Hemodialysis system |
| Root cause | Device Design |
| 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 affec |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182940 | Surdial DX Hemodialysis System Nipro Medical Corporation, Jul 19, 2019 |