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

EZ Breathe Medication Cup recalled by Nephron Pharmaceuticals

Nephron Pharmaceuticals is recalling EZ Breathe Medication Cup, 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 codesLots #120902, Lot # 120903 and Lot # 120904

Quantity recalled750 Medications Cups

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-1373-2013
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 Medication Cup. 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

Why was it recalled?

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

Which lots are affected?

Lots #120902, Lot # 120903 and Lot # 120904

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

Other products in this recall event

2 other products · FDA event 65070

Reported	Class	Recall	Company	Reason	Where
5 Jun 2013	CLASS I	EZ Breathe Atomizer recalled by Nephron Pharmaceuticals	Nephron Pharmaceuticals	Choking Hazard	Nationwide
5 Jun 2013	CLASS I	AsthmaNefrin Starter Kit contains ten AsthmaNefrin vials recalled	Nephron Pharmaceuticals	Choking Hazard	Nationwide

More recalls from Nephron Pharmaceuticals

All 16

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