Otsuka ICU Medical LLC
Otsuka ICU Medical LLC appears in FDA public data with 3 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0180-2026, Class I) was initiated on October 29, 2025.
Summary
- Total Recalls
- 3 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0180-2026 | Class I | POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx | October 29, 2025 |
| D-0181-2026 | Class I | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, R | October 29, 2025 |
| D-0143-2026 | Class II | 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 6004 | October 27, 2025 |