Dozens of companies recall their medical devices every month. A recall
happens when something wrong happened with the device, like a bad labeling or a
bad sterilization. It's the responsibility of the manufacturer to warn ALL
their customers and the government agencies that a given lot or batch of
products has a defect. The batches shall be destroyed or sent back to the
manufacturer for further analysis.
That's what happened to Pfizer with its Rheumatology Calculator, a smartphone
app used to compute a score to assess the desease of patients according to
complex algorithms. There is a bug in the app and it gives wrong results.