Mallinckrodt One-Way Valve Recall: Stuck Valve May Reduce Oxygen Flow

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Contact the company & request your remedy

Recalling firmMallinckrodt Manufacturing LLC6603 Femrite Dr · Madison, WI 53718-6801

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Mallinckrodt is recalling One-Way Valves (part numbers 91346 and 50412) used with ventilators because they may stick and reduce oxygen flow. This could lead to inadequate ventilation for patients using medical devices.

Why it’s dangerous

The valve may stick, preventing or reducing the flow of oxygen or ventilated air. This could lead to inadequate ventilation for patients, potentially causing health complications.

Who’s affected

Patients using ventilators with the recalled valves are most at risk. Healthcare providers and families using these valves for medical purposes may also be affected.

How to tell if you have this one

Check for part numbers 91346 (single piece) or 50412 (pack of 5) used with ventilators. Lot codes include 74L2001714, 74L2001715, 74L2001716, 74M2001125, or 74B2100237.

Brand
Mallinckrodt
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Valve Model
Identify if your valve is part #91346 (1 piece) or part #50412 (pack of 5) used with ventilators.
Contact Manufacturer
Reach out to Mallinckrodt Manufacturing LLC for replacement or guidance on next steps.

✎ GovInfoNow

Questions people ask

What part numbers are affected?

Part #91346 (1 piece) and part #50412 (pack of 5) used with ventilators.

What lot codes are affected?

Lot codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237.

How do I know if my valve is recalled?

Check for part numbers 91346 or 50412 used with ventilators and the listed lot codes.

Take action

Contact Mallinckrodt

We’ve drafted a message you can send Mallinckrodt to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2450-2023 — Mallinckrodt Mallinckrodt

Hello,

I own a Mallinckrodt that is covered by recall Z-2450-2023 from Mallinckrodt.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2450-2023 (August 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2450-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

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

Use caution until it’s fixed