DFI Co., Ltd. Recalls

7 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (7)

April 2, 2026
One Step UTI in vitro diagnostic test REF: 3374
The devices were distributed without required FDA premarket clearance or approval.
Class II
April 2, 2026
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
The devices were distributed without required FDA premarket clearance or approval.
Class II
April 2, 2026
One Step 10A in vitro diagnostic test
The devices were distributed without required FDA premarket clearance or approval.
Class II
April 2, 2026
Uric Acid in vitro diagnostic test REF: 31H0P
The devices were distributed without required FDA premarket clearance or approval.
Class II
April 2, 2026
One Step pH in vitro diagnostic test REF: 31I4P
The devices were distributed without required FDA premarket clearance or approval.
Class II
April 2, 2026
One Step K in vitro diagnostic test REF: 81A4
The devices were distributed without required FDA premarket clearance or approval.
Class II
April 2, 2026
One Step P in vitro diagnostic test REF: 8194
The devices were distributed without required FDA premarket clearance or approval.
Class II

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.