Reported Jan 10, 2024 · Ongoing
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5…
Insulet Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Insulet Corporation · 50 & 100 Nagog Park · Acton, MA · 01720-3440
Is this the product you have?
- Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current)
- USPT-000599- Omnipod 5 App Software Package (provided through Google Play)
- EUPT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump
- Lot codes and dates
- UDI/Model/NDC Number"
- Omnipod 5 App Software UDI1038508112030 "
- EU locked-down Controller UDI10385083000190 and 10385083000206
- Amount recalled
- 27000 users
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.
Using this product could cause serious injury, illness or death — stop using it now.
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