FDA Medical devices recall ·
healthmark ProChek-II, Model Number PT-313, PT-201-12 recall
- Recall number
- Z-3031-2026
- Date
- (initiated July 29, 2026)
- Company / brand
- Healthmark Industries Co., Inc.
18600 Malyn Blvd, Fraser, MI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5090 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
healthmark ProChek-II, Model Number PT-313, PT-201-12
Why was it recalled?
Test manufactured with an expired ingredient which may present as either a false negative or positive.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
PT-313 - Serial/Lot Numbers: 3000535312, 3000535333, 3000536416, 3000536423, 3000537810, 3000537822, 3000542453, 3000545623, 3000550099, 3000550512, 313069, 313072, 313073, 313074, 313075, 313076, 313077, 313078, 313079, 313080, 313081, 313082, 313083, 313084, 313085, 313086, 313087, 313088, 313089, 313090, 313091, 313092, 313093, 313094, 313095, 313096, 313097, 313098, 313099, 313100, 313101, 313102, 313106, 313107; H-PT-201-12 - Serial/Lot Numbers: 7P0110, 7P0111, 7P0113, 7P0122.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3031-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.