- Recalling firm
- Healthmark Industries Co., Inc.
- Reason for recall
- Product does not have FDA clearance.
- Affected products (lot / model / serial)
- No UDI. All lots affected.
- Units affected
- 4,291,797
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Fraser, MI, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1943-2026
- Recall initiated
- March 12, 2026
- FDA classification date
- April 24, 2026
- FDA report date
- May 6, 2026
- FDA event ID
- 98627
- Last updated on HTM Vibe
- July 24, 2026