Recall Atlas

Otsuka ICU Medical recalls

2 official recalls and safety alerts involving Otsuka ICU Medical since 2025-11, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Otsuka ICU Medical or the relevant agency.

  1. 2025-11-26
  2. US
    Drugs & medicalClass I

    Otsuka ICU Medical LLC recalls POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake…

    Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq

    FDA · DrugOtsuka ICU Medical LLCUS Nationwide.Official notice →
  3. 2025-11-05
  4. US
    Drugs & medicalClass II

    Otsuka ICU Medical LLC recalls 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

    Lack of Assurance of Sterility: Potential for flexible container leaks.

    FDA · DrugOtsuka ICU Medical LLCDistributed Nationwide in the USA.Official notice →