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All product recalls associated with Pharmaceutical Innovations, Inc..
Total Recalls
451
Past Year
40
Class I (Serious)
5
Most Recent
Sep 2025
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.
The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.
Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the new IEC standard 60601 1 2, 4th edition
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.