INOmax DSIR - — Class II medical device recall Z-1745-2022
Ongoing recall by Mallinckrodt, LLC., reported 2022-09-21. The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgr
| Recall number | Z-1745-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mallinckrodt, LLC., Bedminster, NJ, United States |
| Recall initiated | 2022-06-23 |
| Classified | 2022-09-15 |
| Reported by FDA | 2022-09-21 |
| Countries outside the US | AE, AR, AT, AU, CA, CH, CL, CZ, DE, DK, EC, EE, ES, FI, FR, GB, HU, IE, IS, IT, LV, MX, NL, NO, PL, PT, RO, SE, SK, UY, ZA |
| Quantity | 4,225 units |
| Reason classes | software |
| Model numbers | 10007 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1745-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.