Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported September 16, 2015
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Insulet Corporation recalled OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(… - a critical-severity action.
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(… was recalled by Insulet Corporation in September 16, 2015. Reason: OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to b…. Check the official notice for the remedy. Verify recall #Z-2484-2015 with the FDA Devices before acting.
The recall
Insulet Corporation issued this critical-severity FDA Devices recall-OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to b….
- Critical
- severity level
- Class I
- classification
- September 16, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2484-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2484-2015) was formally reported on September 16, 2015, with the manufacturer initiating the action on July 13, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Insulet Corporation is listed as the recalling firm, operating out of Billerica, MA. Federal records list the affected scope as 24829 boxes Expanded: 26,230.9 boxes.
The documented reason for this recall is: OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin Distribution data in the federal record shows the product reached: Worldwide Distribution: US (Nationwide) and country of: Switzerland.. 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
24829 boxes Expanded: 26,230.9 boxes
Related Recalls
6
3 from same agency
Product description
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Reason for recall
OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2484-2015 |
| Date reported | September 16, 2015 |
| Date initiated | July 13, 2015 |
| Recalling firm | Insulet Corporation |
| Firm location | Billerica, MA |
| Affected scope | 24829 boxes Expanded: 26,230.9 boxes |
| Distribution | Worldwide Distribution: US (Nationwide) and country of: Switzerland. |
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-2484-2015) 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¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.. Recalled by Insulet Corporation. Units affected: 24829 boxes Expanded: 26,230.9 boxes.
Why was this product recalled? ▼
OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 16, 2015. Severity: Critical. Recall number: Z-2484-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (Nationwide) and country of: Switzerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2484-2015) 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 September 16, 2015. 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.