FDA Medical devices recall ·
The failure occurs if a user on the Omnipod 5 iOS application selects and… recall
- Recall number
- Z-0132-2026
- Date
- (initiated September 11, 2025)
- Company / brand
- Insulet Corporation
50 & 100 Nagog Park, Acton, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 174,013 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0132-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.