healthmark ProChek-W Protein Test for Robotic Arms — Class II medical device recall Z-3032-2026
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-3032-2026 |
|---|---|
| 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 | 53 units |
| Lot numbers | 200035, 200036, 200037, 200038, 200039, 200040, 30028 |
| Model numbers | PT-SQ-001 |
Product
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
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-3032-2026. 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.