Omnipod 5 app recalled because magnifying a field duplicates typed digits
Insulet is recalling 174,013 units of the Omnipod 5 iOS app because using the iPhone magnifier on a manual entry field while typing can duplicate a digit.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a duplicated digit in a dosing entry can produce a substantial dosing error, and no injuries are reported.
Plain-English summary
The Omnipod 5 iOS application, all software versions 2.X.X, UDI 10385083000459, is being recalled.
The failure occurs if a user 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, which could result in errors in manual entry of digits, with examples given including bolus entry, insulin-to-carbohydrate ratio and the bolus calculator.
The recall covers 174,013 units, distributed nationwide in the United States. The FDA has classified the action as Class II.
Users should follow Insulet's instructions and check entered values on screen before confirming them.
The recalled product
- 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.
- Manufacturer
- Insulet Corporation
- Affected units
- 174,013
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X
Distribution
Distributed nationwide across the United States.
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