Neo-Tee T-Piece Resuscitator — Class I medical device recall Z-0004-2025
Ongoing recall by Mercury Enterprises, Inc. dba Mercury Medical, reported 2024-10-09, distributed in FL, IN, MI, PA, SC. Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
| Recall number | Z-0004-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mercury Enterprises, Inc. dba Mercury Medical, Clearwater, FL, United States |
| Recall initiated | 2024-08-30 |
| Classified | 2024-10-02 |
| Reported by FDA | 2024-10-09 |
| Distributed | FL, IN, MI, PA, SC |
| Quantity | 1,300 units |
| UPC / GTIN / UDI-DI | 10641043508053, 10641043508329, 30641043508057, 30641043508323 |
| Lot numbers | 2417650805, 2417750805, 2417850832, 2423550832 |
| Model numbers | 1050805, 1050832 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0004-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.