Class II

Medical Device Recall: healthmark ProChek-II, Model Number PT-313, PT-201-12

Healthmark Industries Co., Inc. · July 29, 2026

Reason for Recall

Test manufactured with an expired ingredient which may present as either a false negative or positive.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.

States Affected

NATIONWIDE

Quantity Affected

5090 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3031-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Healthmark Industries Co., Inc. Medical Device Recall: healthmark ProChek-II, Model Number PT-313, PT-201-12 | SafeCheck