Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported June 5, 2013
EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Nephron Pharmaceuticals Corp. recalled EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respir… - a critical-severity action.
EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respir… was recalled by Nephron Pharmaceuticals Corp. in June 5, 2013. Reason: Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.. Check the official notice for the remedy. Verify recall #Z-1371-2013 with the FDA Devices before acting.
The recall
Nephron Pharmaceuticals Corp. issued this critical-severity FDA Devices recall-Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard..
- Critical
- severity level
- 604 units
- affected scope
- Class I
- classification
- June 5, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1371-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1371-2013) was formally reported on June 5, 2013, with the manufacturer initiating the action on April 30, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Nephron Pharmaceuticals Corp. is listed as the recalling firm, operating out of Orlando, FL. Federal records list the affected scope as 604 each.
The documented reason for this recall is: Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. Distribution data in the federal record shows the product reached: 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,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
604 each
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1371-2013 |
| Date reported | June 5, 2013 |
| Date initiated | April 30, 2013 |
| Recalling firm | Nephron Pharmaceuticals Corp. |
| Firm location | Orlando, FL |
| Affected scope | 604 each |
| Distribution | 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 co… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1371-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.. Recalled by Nephron Pharmaceuticals Corp.. Units affected: 604 each.
Why was this product recalled? ▼
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2013. Severity: Critical. Recall number: Z-1371-2013.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1371-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 5, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.