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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65070

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 30, 2013
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Nephron Pharmaceuticals Corp.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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

Z-1371-2013
Recall number
Z-1371-2013
Initiated
April 30, 2013
Classification
Class I
Status
Terminated
Quantity
604 each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.

device · product 2 of 3

AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.

Z-1372-2013
Recall number
Z-1372-2013
Initiated
April 30, 2013
Classification
Class I
Status
Terminated
Quantity
241,538 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.

device · product 3 of 3

EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.

Z-1373-2013
Recall number
Z-1373-2013
Initiated
April 30, 2013
Classification
Class I
Status
Terminated
Quantity
750 Medications Cups

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lots #120902, Lot # 120903 and Lot # 120904

Distribution pattern

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.