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All product recalls associated with Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd..
Total Recalls
1000
Past Year
593
Class I (Serious)
65
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Cross Contamination with Other Products
Potential of the nozzle separating during patient use.
Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.