One Step UTI Test Recall Issued by FDA
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
DFI Co., Ltd. is recalling 2,423 units of One Step UTI in vitro diagnostic tests distributed without required FDA premarket clearance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 26, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
DFI Co., Ltd. initiated a voluntary recall of One Step UTI in vitro diagnostic tests because the devices were distributed without required FDA premarket clearance or approval. The recall is classified as Class II.
Which Products Are Affected
- Product: One Step UTI in vitro diagnostic test
- REF: 3374
- UDI: 08806141303480
- Lots: 241023, 250625, 250905
- Quantity: 2,423 units
- Distribution: US nationwide in FL and PA, plus England
- Recall Number: Z-2083-2026
What You Should Do
Consumers in possession of the affected products should contact the recalling firm for further instructions regarding the recall.
Why This Matters
The recall affects diagnostic devices distributed across multiple states and internationally without proper regulatory clearance.
Source
FDA recall Z-2083-2026 (Event ID 98739)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (841 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.