Recall database

Nitroprusside, Ketones (Urinary, Non-Quant.) recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-2087-2026

DFI Co., Ltd. recalls One Step K in vitro diagnostic test REF: 81A4

The devices were distributed without required FDA premarket clearance or approval.

Ketones (Urinary, Non-Quant.) Nitroprusside
No Marketing Application

DFI Co., Ltd.May 13, 2026

Class IIOngoingZ-1258-2026

Changchun Wancheng Bio-Electron Co., Ltd. recalls The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers;…

Ketones (Urinary, Non-Quant.) Nitroprusside
No Marketing Application

Changchun Wancheng Bio…Feb 11, 2026