The failure occurs if a user on the Omnipod 5 iOS… recallZ-0132-2026 · Insulet Corporation · initiated Sep 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Insulet Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Software design
What the company is doing
Insulet notified both healthcare professionals and users on about 09/11/2025 via URGENT: Medical Device Correction letter. Instructions included that an update to the application will be pushed to all devices and should be implemented by users. Users were also requested to confirm receipt and acknowledgement of the notification but selecting the "acknowledgement button" in the email.
Recall details
- Recall number
- Z-0132-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 11, 2025
- Posted by the FDA
- Oct 10, 2025
- Recalling firm
- Insulet Corporation
- Quantity
- 174,013 units
- Product code
- QRX
- FDA submissions
- K231826
- Distribution
- US Nationwide distribution.
Product description
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.
Code information (models, lots, serial numbers)
Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Omnipod 5 Controller APP M009-2S-APInsulet Corporation · Continuous Glucose Monitor Informed Insulin Dose Calculator1 recall20 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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