← FDA ENFORCEMENT
Z-1943-2026Class II
Healthmark Industries Co., Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Healthmark Industries Co., Inc.
Product type
Device
Status
Ongoing
Report date
2026-05-06
Distribution
US Nationwide distribution.
Firm state
MI
Product quantity
4,291,797
Initiated by
Voluntary: Firm initiated
Reason for recall
Product does not have FDA clearance.
Product description
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Code / lot info
No UDI. All lots affected.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →