Mallinckrodt Manufacturing LLC: Medical Device Recall in 2023 - (Recall #: Z-2450-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.

Product Classification:

Class I

Date Initiated: August 8, 2023

Date Posted: September 20, 2023

Recall Number: Z-2450-2023

Event ID: 92799

Reason for Recall:

The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.

Status: Ongoing

Product Quantity: 13,602 units

Code Information:

a) UDI/DI 10810055283460, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237; b) UDI/DI 10810055283467, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated