Insulet recalls Omnipod 5 Android app over software error, FDA says

The FDA announced that Insulet recalled its Omnipod 5 Android app due to a software error when the user enters a bolus amount less than 1 unit without putting a leading zero before the decimal point. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death, the agency said in a statement. Due to this error, when entering a bolus dose of insulin less than 1 unit, the SmartBolus calculator does not register the decimal point if it is the first character entered. There have been 2 reported injuries. There have been no reports of death.