MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved… — Class II medical device recall Z-0421-2026
Ongoing recall by Mozarc Medical US LLC, reported 2025-11-12, distributed nationwide. A potential issue with the seal integrity of header bag packaging.
| Recall number | Z-0421-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mozarc Medical US LLC, Mansfield, MA, United States |
| Recall initiated | 2025-10-17 |
| Classified | 2025-11-04 |
| Reported by FDA | 2025-11-12 |
| Distributed | Nationwide (US) |
| Quantity | 3,258 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10884521127890, 20884521127897 |
| Lot numbers | 2430500021 |
| Model numbers | 8888101001HP |
Product
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
Reason for recall
A potential issue with the seal integrity of header bag packaging.
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-0421-2026. 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.