← FDA ENFORCEMENT
Z-1943-2026Class II

Healthmark Industries Co., Inc.

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 openFDA enforcement API. 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.