DFI recalls

DFI has 7 recalls on record with the FDA and USDA, the earliest in 2026 and the latest reported on 13 May 2026. 7 are still ongoing. 7 were reported in the last 12 months.

Total recalls7since 2026

Last 12 months7reported

Class I00% of total

Ongoing7latest 13 May 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 7May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 7 100%Class III 0 0%

Why dfi is recalled

Other Reasons7100%

Product types

Test Kits & Diagnostics7100%

By year

20267100%

Ongoing dfi recalls

7 active

Reported	Class	Recall	Company	Reason	Where
13 May 2026Device	CLASS II	One Step UTI in vitro diagnostic test recalled by DFI Co	DFI	Other	Nationwide
13 May 2026Device	CLASS II	One Step 10A in vitro diagnostic test recalled by DFI Co	DFI	Other	Nationwide
13 May 2026Device	CLASS II	One Step pH in vitro diagnostic test recalled by DFI Co	DFI	Other	Nationwide
13 May 2026Device	CLASS II	One Step P in vitro diagnostic test recalled by DFI Co	DFI	Other	Nationwide
13 May 2026Device	CLASS II	Qucare Total Cholesterol in vitro diagnostic test recalled by DFI Co	DFI	Other	Nationwide
13 May 2026Device	CLASS II	Uric Acid in vitro diagnostic test recalled by DFI Co	DFI	Other	Nationwide

All dfi recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
13 May 2026Device	CLASS II	One Step UTI in vitro diagnostic test recalled by DFI Co	DFI	Other	Nationwide
13 May 2026Device	CLASS II	One Step 10A in vitro diagnostic test recalled by DFI Co	DFI	Other	Nationwide
13 May 2026Device	CLASS II	One Step pH in vitro diagnostic test recalled by DFI Co	DFI	Other	Nationwide
13 May 2026Device	CLASS II	One Step P in vitro diagnostic test recalled by DFI Co	DFI	Other	Nationwide
13 May 2026Device	CLASS II	Qucare Total Cholesterol in vitro diagnostic test recalled by DFI Co	DFI	Other	Nationwide
13 May 2026Device	CLASS II	Uric Acid in vitro diagnostic test recalled by DFI Co	DFI	Other	Nationwide
13 May 2026Device	CLASS II	One Step K in vitro diagnostic test recalled by DFI Co	DFI	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.