The Recall Desk
ModerateFDA (Devices)·Z-2083-2026·Announced 2026-05-13

One Step UTI in vitro diagnostic test recalled for missing FDA approval

DFI Co., Ltd. is recalling the One Step UTI in vitro diagnostic test (REF: 3374) because it was distributed without required FDA premarket clearance or approval.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recalls without reported adverse events or injuries typically fall in the Moderate range. The hazard here is regulatory non-compliance rather than an identified safety defect or reported harm.

Plain-English summary

DFI Co., Ltd. is recalling the One Step UTI in vitro diagnostic test (REF: 3374) due to distribution without required FDA premarket clearance or approval. The affected product was distributed nationwide in Florida and Pennsylvania, as well as in England.

Consumers who have this device should stop using it and contact their healthcare provider or DFI Co., Ltd. for further instructions.

The recalled product

Product
One Step UTI in vitro diagnostic test REF: 3374
Manufacturer
DFI Co., Ltd.
Category
Medical Device — In vitro diagnostic test
Hazard
Affected units
2,423

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI: 08806141303480/ Lot: 241023
  • 250625
  • 250905

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 7 recalled by DFI Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · DFI Co., Ltd.

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Same hazard · unauthorized distribution

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