Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported January 10, 2024
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.
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 th…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Insulet Corporation recalled Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current… - a critical-severity action.
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current… was recalled by Insulet Corporation in January 10, 2024. Reason: The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolu…. Check the official notice for the remedy. Verify recall #Z-0591-2024 with the FDA Devices before acting.
The recall
Insulet Corporation issued this critical-severity FDA Devices recall-The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolu….
- Critical
- severity level
- Class I
- classification
- January 10, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0591-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0591-2024) was formally reported on January 10, 2024, with the manufacturer initiating the action on November 30, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Insulet Corporation is listed as the recalling firm, operating out of Acton, MA. Federal records list the affected scope as 27000 users.
The documented reason for this recall is: 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 t… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Germany and UK.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
27000 users
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0591-2024 |
| Date reported | January 10, 2024 |
| Date initiated | November 30, 2023 |
| Recalling firm | Insulet Corporation |
| Firm location | Acton, MA |
| Affected scope | 27000 users |
| Distribution | Worldwide distribution - US Nationwide and the countries of Germany and UK. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0591-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Insulet Corporation. Units affected: 27000 users.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on January 10, 2024. Severity: Critical. Recall number: Z-0591-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Germany and UK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0591-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 10, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.