CLASS I Device recall · Reported 5 Jun 2013 · FDA Enforcement Report

EZ Breathe Atomizer recalled by Nephron Pharmaceuticals

Nephron Pharmaceuticals is recalling EZ Breathe Atomizer, distributed nationwide in the US. The recall was initiated on 30 Apr 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel # 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

Quantity recalled604 each

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1371-2013
FDA event ID: 65070
Recalling firm: Nephron Pharmaceuticals, Orlando, FL
Classification: Class I
Status: Terminated
Recall initiated: 30 Apr 2013
FDA classified: 29 May 2013
Reported: 5 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Choking Hazard
Device type: CPAP & Ventilators

Timeline

30 Apr 2013	Recall initiated by company
29 May 2013	Classified by FDA	+29 days
5 Jun 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and the countries of Guatemala, Poland, Panama, and United Kingdom.

Nationwide Alabama Arizona California Colorado Connecticut District of Columbia Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Maryland Minnesota Missouri Mississippi New Jersey New Mexico Nevada

Questions about this recall

Is EZ Breathe Atomizer recalled?

Yes. Nephron Pharmaceuticals recalled EZ Breathe Atomizer on 30 Apr 2013. The recall is Class I and its status is Terminated. Recall number Z-1371-2013.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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