The FDA has posted 7 enforcement recalls from DFI Co., Ltd. since 2025, none of them Class I (most serious). Most recent report: May 13, 2026.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
Firm name as filed with the FDA: “DFI Co., Ltd.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.