INOmax recallZ-2450-2023 · Mallinckrodt Manufacturing LLC · initiated Aug 8, 2023
Open, Classified
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 Mallinckrodt Manufacturing LLC 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
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
FDA root cause category: Under Investigation by firm
What the company is doing
Mallinckrodt Pharmaceuticals issued an URGENT: MEDICAL DEVICE RECALL NOTICE to its consignees on 08/08/2023 via FedEx. the notice explained the issue, risks associated with the failure, and requested the return of the device.
Recall details
- Recall number
- Z-2450-2023
- Status
- Open, Classified
- Initiated by the company
- Aug 8, 2023
- Posted by the FDA
- Sep 9, 2023
- Recalling firm
- Mallinckrodt Manufacturing LLC
- Quantity
- 13,602 units
- Product code
- BZO
- Distribution
- Worldwide Distribution
Product description
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Code information (models, lots, serial numbers)
a) UDI/DI 10810055283460, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237; b) UDI/DI 10810055283467, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INOmax 91346Mallinckrodt Manufacturing LLC · Set, Tubing And Support, Ventilator (W Harness)1 recall0 reports
Product lines
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 16, 2026. Text above is shown as published by the FDA.
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