INOMAX DSIR Nitric Oxide delivery system, Model 10007… recallZ-0575-2015 · INO Therapeutics (dba Ikaria) · initiated Oct 17, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from INO Therapeutics (dba Ikaria) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board.
FDA root cause category: Process change control
What the company is doing
Ikaria contacted consignees by phone beginning 10/17/2014. A follow-up letter was sent to customers beginning 10/22/2014. The letter described the issue, requested that affected devices not be used and to return to Ikaria. Customers with questions can contact Ikaria Customer Care at 1-877-566-9466.
Recall details
- Recall number
- Z-0575-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 17, 2014
- Posted by the FDA
- Dec 12, 2014
- Recalling firm
- INO Therapeutics (dba Ikaria)
- Quantity
- 9
- Product code
- MRN
- FDA submissions
- K131686
- Distribution
- US Distribution in states of: VA and PA only.
Product description
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.
Code information (models, lots, serial numbers)
Serial Numbers: DS20080152, DS20090925, DS20101076, DS20101499, DS20110886, DS20110965, DS20120099, DS20120150, DS20120169.
Other devices under the same FDA submission
1 device cleared under K131686 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- INOmax DSIR Plus 10007Mallinckrodt Manufacturing LLC · Analyzer, nitrogen dioxide3 deaths713 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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