Z-1943-2026 Class II Ongoing

Recalled by Healthmark Industries Co., Inc. — Fraser, MI

Recall Details

Product Type
Devices
Report Date
May 6, 2026
Initiation Date
March 12, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,291,797

Product Description

Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style

Reason for Recall

Product does not have FDA clearance.

Distribution Pattern

US Nationwide distribution.

Code Information

No UDI. All lots affected.