# FDA recall Z-1578-2023

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2023-03-21.

## Product

COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units

## Reason for recall

Custom sheath Introducer contains  incorrect needle size

## Distribution

US Distribution to state of: Minnesota

## Key facts

- **Recall number:** Z-1578-2023
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-21
- **Report date:** 2023-05-17

- **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-1578-2023

## Citation

> AI Analytics. FDA recall Z-1578-2023. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1578-2023. Source: US FDA. Licensed CC0.

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