healthmark ProChek-II recall (Healthmark Industries Co., Inc.)
Medical deviceClass IIOngoing
Summary: Healthmark Industries Co., Inc. is recalling healthmark ProChek-II, Model Number PT-313, PT-201-12. Reason: Test manufactured with an expired ingredient which may present as either a false negative or positive.
What is being recalled
healthmark ProChek-II, Model Number PT-313, PT-201-12
Why
Test manufactured with an expired ingredient which may present as either a false negative or positive.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3031-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 29, 2026 |
| Reported | September 2, 2026 |
| Company | Healthmark Industries Co., Inc. |
| Company location | Fraser, MI, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 5090 units |
More recalls from Healthmark Industries Co., Inc. · all medical device recalls · recalls from July 2026