# FDA recall Z-1874-2024

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2024-03-14.

## Product

Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 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.

## Distribution

Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.

## Key facts

- **Recall number:** Z-1874-2024
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-14
- **Report date:** 2024-05-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1874-2024

## Citation

> AI Analytics. FDA recall Z-1874-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1874-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
