Prelude Guide Sheath Roadster — Class II medical device recall Z-1875-2024
Ongoing recall by Merit Medical Systems, Inc., reported 2024-05-29, distributed nationwide. Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
| Recall number | Z-1875-2024 |
|---|---|
| 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 | 2024-03-14 |
| Classified | 2024-05-20 |
| Reported by FDA | 2024-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, NZ |
| Quantity | 27 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00884450770771 |
| Lot numbers | H2817178 |
| Model numbers | PG6F45S018 |
Product
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Reason for recall
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
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-1875-2024. 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.