FDA (Devices) recall action 77188
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medtronic is recalling 65,959 MiniMed 630G insulin pumps because the device may become temporarily stuck and the keypad may become unresponsive.
Medtronic is recalling 6,573 MiniMed 620G insulin infusion pumps because the keypad may become unresponsive and the pump may become temporarily stuck.
Medtronic is recalling 117,239 MiniMed 640G insulin pumps because the keypad may become unresponsive, potentially preventing users from adjusting insulin delivery.
Medtronic is recalling 117,239 MiniMed 670G insulin pumps because the keypad may become unresponsive and the pump may become temporarily stuck.