Quick Facts at a Glance
- Recall Date
- September 11, 2025
- Hazard Level
- HIGH
- Brand
- Insulet
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Insulet
- Product type
- Mobile App Software (iOS)
- Model numbers
- Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 11, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Insulet Corporation or your healthcare provider for instructions. Notification method: E-Mail
About This Product
Omnipod 5 is a wireless insulin pump system controlled by a mobile app. The iOS app manages bolus delivery and dosing calculations. The recall concerns a software bug in the iOS app that can alter dose entries when magnifying digits.
Why This Is Dangerous
The magnify-and-enter bug can duplicate a single digit, leading to incorrect bolus, ratio settings, or calculator results. This may cause over-delivery of insulin and hypoglycemia.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The issue directly affects diabetes management. It creates an immediate risk for users who rely on precise insulin dosing and may require urgent medical monitoring.
Practical Guidance
How to identify if yours is affected
- Confirm you own an Omnipod 5 system and use the iOS app.
- Check if your app version is 2.X.X (any 2.x version is affected).
- Review Omnipod 5 app updates and recall notices from Insulet and the FDA.
Where to find product info
Official recall information is available on Insulet’s site and the FDA recall enforcement page. Look for Z-0132-2026.
What timeline to expect
Remediation timelines vary; expect updates within weeks to months. Recipients may need software updates or alternative management guidance.
If the manufacturer is unresponsive
- Document all communications with Insulet.
- Escalate to FDA recall channels if Insulet is unresponsive.
- Consult your healthcare provider for guidance on safe insulin management during the recall period.
How to prevent similar issues
- Keep app and device software updated only through official channels.
- Verify any new update instructions from Insulet before applying.
- Report any dosing anomalies to a healthcare professional immediately.
Documentation advice
Maintain copies of recall notices, emails from Insulet, and records of any dosing events or communication with providers.
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Product Details
Model numbers: Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X. Where sold: United States nationwide distribution. When sold: Recall date 2025-09-11. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- High risk, potential for hypoglycemia
- All software versions 2.X.X affected
- US nationwide distribution
- Remedy: stop use and follow recall instructions
- Notification method: Email
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