Recall Z-0912-2026— Nipro Medical Corporation

Name: FDA recall Z-0912-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-27

Class II · Ongoing

Class II FDA medical device recall by Nipro Medical Corporation, initiated 2025-10-27. It names one FDA 510(k) clearance: K182940. Product: Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only. Reason: Screw may loosen or fallout of Hemodialysis system.

Recalling firm: Nipro Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-10-27
Firm location: Doral, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K182940 — Surdial DX Hemodialysis SystemNipro Medical Corporation·cleared 2019-07-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only

Reason for recall

Screw may loosen or fallout of Hemodialysis system

Data sourced from openFDA. This site is unofficial and independent of the FDA.