Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Mallinckrodt One-Way Valve Recalled by Mallinckrodt Manufacturing LLC Due to The One-Way Valve, 22F x 22M may stick...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mallinckrodt Manufacturing LLC directly.
Affected Products
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Quantity: 13,602 units
Why Was This Recalled?
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Where Was This Sold?
Worldwide Distribution
About Mallinckrodt Manufacturing LLC
Mallinckrodt Manufacturing LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report