Overview of recall records associated with Powers Medical Devices, LLC, including dates, categories and classifications where available.
Classification mix: Class II: 1.
PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k).
This page summarizes recall records in which the official source identifies Powers Medical Devices, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
