Z-0132-2026Class II

The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field...

Name: Z-0132-2026 The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field...
Creator: Insulet Corporation
Published: 2025-09-11
License: https://open.fda.gov/license/

Insulet Corporation / initiated 2025-09-11 / Open, Classified / root cause: software

FDA source

Insulet Corporation began a recall of 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... on 2025-09-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0132-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-11
Posted: 2025-10-10
Recalling firm: Insulet Corporation
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.
Product code: QRX Continuous Glucose Monitor Informed Insulin Dose Calculator
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 174,013 units
Distribution: US Nationwide distribution.
Product codes and lots: Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0132-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0132-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10

Product code QRX

K231826Class IIOmnipod 5 ACE PumpInsulet Corporation / cleared 2023-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)