FDA applicant

Mallinckrodt, Inc.

St. Louis, MO2 decisions2000–20012 recalls

FDA records 2 decisions for Mallinckrodt, Inc. (St. Louis, MO) from 2000 to 2001: 2 510(k) clearances. Most are in product codes MNT (Continuous, Minimal Ventilatory Support…) and JOH (Tube Tracheostomy And Tube Cuff). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Mallinckrodt, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mallinckrodt, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mallinckrodt, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Mallinckrodt”

FDA records each applicant name separately; these may or may not be the same firm.

Mallinckrodt Critical Care 92 Mallinckrodt Medical 43 Mallinckrodt Group, Inc. 27 Mallinckrodt Inc., Liebel-Flarsheim Business 8 Mallinckrodt Developpement France 7 Mallinckrodt Manufacturing, LLC 4 Mallinckrodt Medical Tpi, Inc. 4 Mallinckrodt Anesthesia Products 3 Mallinckrodt Dar S.R.L. 2 Mallinckrodt Sensor Systems, Inc. 2

Mallinckrodt, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Mallinckrodt”