EZ Breathe Atomizer Model # EZ-100 — Class I medical device recall Z-1371-2013
Terminated recall by Nephron Pharmaceuticals Corp., reported 2013-06-05, distributed nationwide. Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
| Recall number | Z-1371-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nephron Pharmaceuticals Corp., Orlando, FL, United States |
| Recall initiated | 2013-04-30 |
| Classified | 2013-05-29 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2016-06-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, GT, PA, PL |
| Quantity | 604 units |
| Lot numbers | R2029A, R2029B, R2039A, R2042A, R2045A, R2047A |
| Model numbers | EZ-100, R2029A, R2029B, R2039A, R2042A, R2045A, R2047A |
Product
EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
Reason for recall
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
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-1371-2013. 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.