CLASS II Device recall · Reported 11 Mar 2015 · FDA Enforcement Report
Ikaria, INOmax DSIR (Delivery System) recalled by INO Therapeutics (
INO Therapeutics ( is recalling Ikaria, INOmax DSIR (Delivery System), distributed nationwide in the US. The recall was initiated on 14 Jan 2015 and the FDA has classified it as Class II.
Check your package
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-1223-2015
- FDA event ID
- 70395
- Recalling firm
- INO Therapeutics (, Madison, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jan 2015
- FDA classified
- 27 Feb 2015
- Reported
- 11 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 14 Jan 2015 | Recall initiated by company | |
| 27 Feb 2015 | Classified by FDA | +44 days |
| 11 Mar 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Where it was distributed
Distribution US nationwide, including AZ, CA, CT, FL, ID, LA, MD, MI, MS, NH, NJ, NV, NY, OK, PA, TX, UT, VA, WV.
Nationwide ArizonaCaliforniaConnecticutFloridaIdahoLouisianaMarylandMichiganMississippiNew HampshireNew JerseyNevadaNew YorkOklahomaPennsylvaniaTexasUtahVirginiaWest Virginia
Questions about this recall
Why was it recalled?
Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted.
Which lots are affected?
Finished Product Serial#. DS20070005 DS20090559 DS20100326 DS20100343 DS20100915 DS20101282 DS20070101 DS20080024 DS20080064 DS20080074 DS20080141 DS20080222 DS20080229 DS20080318 DS20090052 DS20090086 DS20090109 DS20090121 DS20090190 DS20090328 DS20090584 DS20090611 DS20090618 DS20090676 DS20090708 DS20090770 DS20090825 DS20090880 DS20090890 DS20090931 DS20090941 DS20100016 DS20100038 DS20100283 DS20100285 DS20100302 DS20100497 DS20100529 DS20100542 DS20100665 DS20100724 DS20100747 DS20100851 DS20100852 DS20100887 DS20100939 DS20101073 DS20101077 DS20101264 DS20101330 DS20101397 DS20101505 DS20110021 DS20110204 DS20110353 DS20110388 DS20110398 DS20110399 DS20110406 DS20110429 DS20110433 DS20110487 DS20110850 DS20110867 DS20110934 DS20110967 DS20111009 DS20111123 DS20111124 DS20111125 DS20111140 DS20111184 DS20111185 DS20111190 DS20111206 DS20120019 DS20120167 DS20120172 DS20120191 DS20120197 DS20100219 DS20100877 DS20110787 DS20110410 DS20080298 DS20100012 DS20100162 DS20100962 DS20100964 DS20110892 DS20110981 DS20070010 DS20070255 DS20080314 DS20090265 DS20090424 DS20090642 DS20090661 DS20090889 DS20100036 DS20100583 DS20101157 DS20101214 DS20101478 DS20111200 DS20120041 DS20070041 DS20090013 DS20090028 DS20090034 DS20090647 DS20090923 DS20100395 DS20100443 DS20101226 DS20101314 DS20101396 DS20101482 DS20101523 DS20111029 DS20111057 DS20111091 DS20111120 DS20120047 DS20120049
Where was it sold?
Distribution US nationwide, including AZ, CA, CT, FL, ID, LA, MD, MI, MS, NH, NJ, NV, NY, OK, PA, TX, UT, VA, WV.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from INO Therapeutics (
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system recalled | INO Therapeutics ( | Labeling Errors | 18 states |
| Device | CLASS II | Inomax Dsir Nitric Oxide delivery system recalled by INO Therapeutics ( | INO Therapeutics ( | Device Malfunction | PA, VA |
| Device | CLASS II | INOmax DSIR recalled by INO Therapeutics ( | INO Therapeutics ( | Device Malfunction | Nationwide |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |