Otsuka ICU Medical recalls

Otsuka ICU Medical has 4 recalls on record with the FDA and USDA, the earliest in 2025 and the latest reported on 21 Sep 2026. 4 are still ongoing. 4 were reported in the last 12 months.

Total recalls4since 2025

Last 12 months4reported

Class I250% of total

Ongoing4latest 21 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 3Nov 0 0 0Feb 0 0 0May 0 0 0Aug 1 0

Severity split

Class I 2 50%Class II 1 25%Class III 0 0%Other/pending 1

Why otsuka icu medical is recalled

Product types

Injectable & IV Drugs375%

Brands

By year

2026125%
2025375%

Ongoing otsuka icu medical recalls

4 active

Reported	Class	Recall	Company	Reason	Where
21 Sep 2026Drug	ANNOUNCED	ICU Medical LLC 0.9% Sodium Chloride Injection recalledICU Medical LLC	Otsuka ICU Medical	Packaging Defects
26 Nov 2025Drug	CLASS I	Potassium Chloride Inj., 20 mEq total in Flexible Container recalledPotassium Chloride	Otsuka ICU Medical	Other	Nationwide
26 Nov 2025Drug	CLASS I	Potassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium Chloride	Otsuka ICU Medical	Other	Nationwide
5 Nov 2025Drug	CLASS II	0.9% Sodium Chloride Injection recalled by Otsuka ICU MedicalSodium Chloride	Otsuka ICU Medical	Sterility	Nationwide

All otsuka icu medical recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
21 Sep 2026Drug	ANNOUNCED	ICU Medical LLC 0.9% Sodium Chloride Injection recalledICU Medical LLC	Otsuka ICU Medical	Packaging Defects
26 Nov 2025Drug	CLASS I	Potassium Chloride Inj., 20 mEq total in Flexible Container recalledPotassium Chloride	Otsuka ICU Medical	Other	Nationwide
26 Nov 2025Drug	CLASS I	Potassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium Chloride	Otsuka ICU Medical	Other	Nationwide
5 Nov 2025Drug	CLASS II	0.9% Sodium Chloride Injection recalled by Otsuka ICU MedicalSodium Chloride	Otsuka ICU Medical	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.