Prelude IDEAL 4 F Hydrophilic Sheath Introducer — Class II medical device recall Z-1434-2025
Ongoing recall by Merit Medical Systems, Inc., reported 2025-04-02. Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect d
| Recall number | Z-1434-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2025-01-27 |
| Classified | 2025-03-24 |
| Reported by FDA | 2025-04-02 |
| Countries outside the US | JP |
| Quantity | 40 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00884450693919 |
| Lot numbers | H3082668 |
| Model numbers | PID4F16021PW/D |
| Expiration dates | 2024-11-14 |
Product
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Reason for recall
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
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-1434-2025. 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.