The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify
Summary
The FDA issued a Class II for The failure occurs if a user on the Omnipod 5 iOS application selects and holds by Insulet Corporation. Reason: 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 ma.
Details
Source
Device Recall
External ID
Z-0132-2026
Action Date
2025-10-22
Status
Ongoing
Category
device
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.
Lot/Code Info: Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X
Quantity Affected: 174,013 units
Reason for Recall
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-11
Company
Acton, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 237 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Insulet Corporation has 17 FDA actions in our database, including 7 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Insulet Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Insulet Corporation have FDA actions?
Insulet Corporation has 17 FDA actions in our database, including 7 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0132-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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