Also in 2016 the FDA recalled Dexcom G4 Platinum and G5 Mobile continuous glucose monitoring system receivers, due to complaints that the audible alarm may not activate the receiver when patients experience low or high glucose levels. This is an essential feature of the device that protects persons with type 1 and type 2 diabetes from experiencing hypoglycemia or hyperglycemia. Without the alarm sounding, persons with diabetes may not know they have low or high blood sugar, and thus could experience an episode of hypoglycemia or hyperglycemia that could end with hospitalization or, in more serious circumstances, death.

Also, the FDA recalled DePuy ASR XL, The FDA cleared this device without clinical testing based on “substantial equivalence” to earlier devices, though such metal-on-metal hips had long been on the agency’s high-priority list for requiring advance clinical trials. The device cause increase in the chromium and cobalt levels in his blood as some people described it as “profound poisoning”, and in an article in the British Medical Journal called it “one of the biggest disasters in orthopaedic history.”

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=96142
https://www.consumerreports.org/cro/magazine/2012/04/cr-investigates-dangerous-medical-devices/index.htm