# FDA recall Z-2530-2025

> **AVID Medical, Inc.** · Class II · device recall initiated 2025-08-04.

## Product

Halyard, ENT PACK. Model Number: JACK421-04.     Convenience kit.

## Reason for recall

Potential for open header bag seals, compromising sterility.

## Distribution

US Nationwide distribution in the state of Florida.

## Key facts

- **Recall number:** Z-2530-2025
- **Recalling firm:** AVID Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-04
- **Report date:** 2025-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Toano, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2530-2025

## Citation

> AI Analytics. FDA recall Z-2530-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2530-2025. Source: US FDA. Licensed CC0.

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