RecallRadar

FDA Device recall Z-1371-2013

EZ Breathe Atomizer Model # EZ-100

On 2013-06-05 the FDA classified a Class I recall of EZ Breathe Atomizer Model # EZ-100 by Nephron Pharmaceuticals, citing possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1371-2013
ClassificationClass I
Statusterminated
Initiated2013-04-30
Published2013-06-05
Last updated2026-09-13 11:53 UTC
CompanyNephron Pharmaceuticals
DistributionUS

Product

EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.

Reason

Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.

Identifiers

code_info
Model # EZ-100 Lots # R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A. Atomizer Serial Number Ranges: 1206034476…Model # EZ-100 Lots # R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A. Atomizer Serial Number Ranges: 1206034476-1206069065 1207003710-1237038299 1207046505-1207081124 1208027421-1208062155 1209000001-1209069179 1209069180-1209069202 1209069203-1209069460 1210000001-1210103680 1210104001-1210104044

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1371-2013%22

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