FDA Class II · Medical device · May 13, 2026
One Step P in vitro diagnostic test REF recall — DFI Co., Ltd.
The devices were distributed without required FDA premarket clearance or approval.
Official ID Z-2088-2026 · Official record ↗
DFI Co recalls
7 recent recalls on record for DFI Co in connected official government data as of October 22, 2026 at 6:00 PM UTC.
Models with recalls
One Step 10A in vitro diagnostic test (1)One Step K in vitro diagnostic test REF (1)One Step P in vitro diagnostic test REF (1)One Step UTI in vitro diagnostic test REF (1)One Step pH in vitro diagnostic test REF (1)QUCARE Total Cholesterol in vitro diagnostic test REF (1)Uric Acid in vitro diagnostic test REF (1)
All DFI Co recalls
FDA Class II · Medical device · May 13, 2026
One Step K in vitro diagnostic test REF recall — DFI Co., Ltd.
The devices were distributed without required FDA premarket clearance or approval.
Official ID Z-2087-2026 · Official record ↗
FDA Class II · Medical device · May 13, 2026
Uric Acid in vitro diagnostic test REF recall — DFI Co., Ltd.
The devices were distributed without required FDA premarket clearance or approval.
Official ID Z-2086-2026 · Official record ↗
FDA Class II · Medical device · May 13, 2026
QUCARE Total Cholesterol in vitro diagnostic test REF recall — DFI Co., Ltd.
The devices were distributed without required FDA premarket clearance or approval.
Official ID Z-2085-2026 · Official record ↗
FDA Class II · Medical device · May 13, 2026
One Step pH in vitro diagnostic test REF recall — DFI Co., Ltd.
The devices were distributed without required FDA premarket clearance or approval.
Official ID Z-2084-2026 · Official record ↗
FDA Class II · Medical device · May 13, 2026
One Step UTI in vitro diagnostic test REF recall — DFI Co., Ltd.
The devices were distributed without required FDA premarket clearance or approval.
Official ID Z-2083-2026 · Official record ↗
FDA Class II · Medical device · May 13, 2026
One Step 10A in vitro diagnostic test recall — DFI Co., Ltd.
The devices were distributed without required FDA premarket clearance or approval.
Official ID Z-2082-2026 · Official record ↗
Verify with the official sources:
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
Compiled from official public-domain government data. Last checked October 22, 2026 at 6:00 PM UTC.