healthmark ProChek-II — Class II medical device recall Z-3031-2026
Ongoing recall by Healthmark Industries Co., Inc., reported 2026-09-02, distributed nationwide. Test manufactured with an expired ingredient which may present as either a false negative or positive.
| Recall number | Z-3031-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Healthmark Industries Co., Inc., Fraser, MI, United States |
| Recall initiated | 2026-07-29 |
| Classified | 2026-08-26 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, FR, HK, KR |
| Quantity | 5,090 units |
| 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 and 9 more |
| Model numbers | PT-201-12, PT-313 |
Product
healthmark ProChek-II, Model Number PT-313, PT-201-12
Reason for recall
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3031-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.