FDA-Device2025-10-22Class II
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.
Hazard
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.
Sold states
US Nationwide distribution.
Affected count
174,013 units
Manufactured in
50 & 100 Nagog Park, Acton, MA, United States
Products
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0132-2026More Insulet Corporation recalls
- FDA-Device2026-07-08Insulet Omnipod Eros insulin pump pods recalled for potential under-delivery due to cannula damage
- FDA-Device2026-07-08Insulet Omnipod DASH Pod recalled for insulin leakage risk during manufacturing
- FDA-Device2026-07-08Insulet Omnipod 5 Pods recalled for insulin leakage risk due to manufacturing defect
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.