CLASS I ONGOING Device recall · Reported 10 Jan 2024 · FDA Enforcement Report
Omnipod 5 App (on compatible Android smartphones) recalled by Insulet
Insulet is recalling Omnipod 5 App (on compatible Android smartphones), distributed nationwide in the US. The recall was initiated on 30 Nov 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0591-2024
- FDA event ID
- 93511
- Recalling firm
- Insulet, Acton, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 30 Nov 2023
- FDA classified
- 4 Jan 2024
- Reported
- 10 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 30 Nov 2023 | Recall initiated by company | |
| 4 Jan 2024 | Classified by FDA | +35 days |
| 10 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Germany and UK.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/Model/NDC Number: " Omnipod 5 App Software UDI: 1038508112030 " EU locked-down Controller UDI: 10385083000190 and 10385083000206
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Germany and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Insulet
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Packaging Defects | Nationwide |
| Device | CLASS I | Omnipod DASH Pod recalled by Insulet | Insulet | Packaging Defects | Nationwide |
| Device | CLASS I | Omnipod 5 Pods recalled by Insulet | Insulet | Packaging Defects | Nationwide |
| Device | CLASS I | Omnipod 5 Pods recalled by Insulet | Insulet | Packaging Defects | Nationwide |
| Device | CLASS II | The failure occurs if a user on the Omnipod 5 iOS recalled by Insulet | Insulet | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 467| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Flex Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Labeling Errors | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |