FDA Devices recall · Reported December 23, 2015
OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Insulet Corporation recalled OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The … - a critical-severity action.
OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The … was recalled by Insulet Corporation in December 23, 2015. Reason: Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.. Check the official notice for the remedy. Verify recall #Z-0394-2016 with the FDA Devices before acting.
The recall
Insulet Corporation issued this critical-severity FDA Devices recall-Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism..
- Critical
- severity level
- Class I
- classification
- December 23, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0394-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
Reason for recall
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0394-2016 |
| Date reported | December 23, 2015 |
| Date initiated | November 2, 2015 |
| Recalling firm | Insulet Corporation |
| Firm location | Billerica, MA |
| Affected scope | 5,179.0 boxes |
| Distribution | Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel. |
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-0394-2016) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026