# FDA recall Z-0504-2023

> **Stradis Medical, LLC dba Stradis Healthcare** · Class II · device recall initiated 2022-11-02.

## Product

HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray

## Reason for recall

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

## Distribution

US nationwide distribution, and Canada.

## Key facts

- **Recall number:** Z-0504-2023
- **Recalling firm:** Stradis Medical, LLC dba Stradis Healthcare
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-02
- **Report date:** 2022-12-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Peachtree Corners, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0504-2023

## Citation

> AI Analytics. FDA recall Z-0504-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0504-2023. Source: US FDA. Licensed CC0.

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