# FDA recall Z-0004-2025

> **Mercury Enterprises, Inc. dba Mercury Medical** · Class I · device recall initiated 2024-08-30.

## Product

Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

## Reason for recall

Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

## Distribution

US distribution to MI, FL, SC, PA, IN. International distribution to Albania.

## Key facts

- **Recall number:** Z-0004-2025
- **Recalling firm:** Mercury Enterprises, Inc. dba Mercury Medical
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-30
- **Report date:** 2024-10-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Clearwater, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0004-2025

## Citation

> AI Analytics. FDA recall Z-0004-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0004-2025. Source: US FDA. Licensed CC0.

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