FDA Enforcement
Class II
Ongoing
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Recall: Z-1943-2026
·
Reported May 6, 2026
Enforcement
- Recall Number
- Z-1943-2026
- Event ID
- 98627
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Healthmark Industries Co., Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 6, 2026
- Initiation Date
- March 12, 2026
- Classification Date
- April 24, 2026
- Address
- 18600 Malyn Blvd, Fraser, MI, 48026-3496, United States
Description
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Reason
Product does not have FDA clearance.
Code Info
No UDI. All lots affected.
Distribution
US Nationwide distribution.
Quantity
4,291,797