Beta Bionics, Inc.
Beta Bionics, Inc.: 3 recalls listed since April 2026 across FDA.
By year
- 20263
By agency
- FDA3
By category
- Medical Device3
All recalls (3)
Beta Bionics iLet Bionic Pancreas
This can lead to hyperglycemia.
Beta Bionics iLet Bionic Pancreas
The iLet Bionic Pancreas software may delay CGM readings, leading to severe hyperglycemia or hypoglycemia.
Beta Bionics iLet Ace Pump Kit and Dosing Decision Software
The iLet Ace Pump Kit and Dosing Decision Software can be bypassed, allowing unauthorized access and potentially causing severe hypoglycemia.