Z-1943-2026 Class II Ongoing
FDA device recall Z-1943-2026 was initiated by Healthmark Industries Co., Inc. on March 12, 2026 and is designated Class II. Reason for recall: Product does not have FDA clearance. The recall status is ongoing. Affected quantity: 4,291,797.
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.