FDA applicant

Mallinckrodt Critical Care

Mchenry, IL92 decisions1976–19891 recall

FDA records 92 decisions for Mallinckrodt Critical Care (Mchenry, IL) from 1976 to 1989: 92 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and DQO (Catheter, Intravascular, Diagnostic). 1 recall is linked to its devices.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Mallinckrodt Critical Care since 2007.

Recalls per year

1in 2023

2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Mallinckrodt Critical Care 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 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, Inc. 2 Mallinckrodt Dar S.R.L. 2 Mallinckrodt Sensor Systems, Inc. 2

Mallinckrodt Critical Care

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”