Z-1745-2022Class II

INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory...

Name: Z-1745-2022 INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory...
Creator: Mallinckrodt, LLC.
Published: 2022-06-23
License: https://open.fda.gov/license/

Mallinckrodt, Inc. / initiated 2022-06-23 / Open, Classified / root cause: software

FDA source

Mallinckrodt, LLC. began a recall of INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way... on 2022-06-23. FDA classified it as Class II and gives the reason as "The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1745-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-23
Posted: 2022-09-13
Recalling firm: Mallinckrodt, Inc.
Product: INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, Model Number: 10007
Product code: MRN Apparatus, Nitric Oxide Delivery
Reason for recall: The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded in 2021 by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected with the INOmax DSIR as instructed in the INOmax DSIR Operators Manual (OM). The INOmax DSIR OM requires the use of a one-way valve with the Leoni Plus ventilator during High Frequency Oscillatory Ventilation mode and warns that use of the device without a one-way valve may result in high Nitric Oxide (NO) delivery.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Mallinkrodt issued via email on 6/23/22 an Urgent Field Safety Notice (FA-R-0023) stating reason for recall, health risk and action to take: Upon receipt of this Field Safety Notice (FSN), INOmax DSIR operators are advised not to use an upgraded Leoni Plus ventilator with the INOmax DSIR. The INOmax DSIR Validated Ventilator List, supplied as Technical Bulletin TB-20005, will be revised to remove the Leoni Plus ventilator and distributed as soon as it is available. A response form is required for this FSN. Please complete the attached form and return as instructed.
Quantity in commerce: 4,225 units OUS
Distribution: Foreign Only: Argentina Australia Austria Beligum Canada Chile Columbia Czech Republic Denmark Ecuador Estonia Finland France Germany Great Britain Hungary Iceland Ireland Italy Latvia Mexico Netherlands Norway Poland Portugal Romania Slovakia South Africa Spain Sweden Switzerland UAE Uruguay
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1745-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1745-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-15

Product code MRN

K061901Class IIIno Therapeutics Inomax Ds (Delivery System), Model 10003Ino Therapeutics / cleared 2006-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)