- Recalling firm
- DFI Co., Ltd.
- Reason for recall
- The devices were distributed without required FDA premarket clearance or approval.
- Affected products (lot / model / serial)
- UDI:08806141302650/ Lot: 241023, 250625, 250905
- Units affected
- 761 units
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
- Firm location
- Gimhae, Korea (the Republic of)
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2087-2026
- Recall initiated
- April 2, 2026
- FDA classification date
- May 6, 2026
- FDA report date
- May 13, 2026
- FDA event ID
- 98739
- Last updated on HTM Vibe
- July 24, 2026