Mesh Style Tip Protectors CSW-03-2 — Class II medical device recall Z-1943-2026
Ongoing recall by Healthmark Industries Co., Inc., reported 2026-05-06, distributed nationwide. Product does not have FDA clearance.
| Recall number | Z-1943-2026 |
|---|---|
| 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 | 2026-03-12 |
| Classified | 2026-04-24 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 4,291,797 |
Product
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Reason for recall
Product does not have FDA clearance.
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-1943-2026. 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.