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U.S. Department of Health and Human Services

Class 2 Device Recall Omnipod 5 Automated Insulin Delivery System. Omnipod 5 iOS application.

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 Class 2 Device Recall Omnipod 5 Automated Insulin Delivery System. Omnipod 5 iOS application.see related information
Date Initiated by FirmSeptember 11, 2025
Date PostedOctober 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0132-2026
Recall Event ID 97597
510(K)NumberK231826 
Product Classification Continuous glucose monitor informed insulin dose calculator - Product Code QRX
ProductThe 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 Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X
FEI Number 3014585508
Recalling Firm/
Manufacturer		 Insulet Corporation
50 & 100 Nagog Park
Acton MA 01720-3440
For Additional Information ContactAngela Geryak Wiczek
978-600-7451
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionInsulet 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 Commerce174,013 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QRX
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