FDA Medical devices recall ·
One Step UTI in vitro diagnostic test recall
- Recall number
- Z-2083-2026
- Date
- (initiated April 2, 2026)
- Company / brand
- DFI Co., Ltd.
388-25 Gomo-Ro, Gimhae, Korea (the Republic of) - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2423 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
One Step UTI in vitro diagnostic test REF: 3374
Why was it recalled?
The devices were distributed without required FDA premarket clearance or approval.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 08806141303480/ Lot: 241023, 250625, 250905
Distribution
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
States: Florida Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2083-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.