Severity
Critical
CriticalClass ITerminated
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-0394-2016) was formally reported on December 23, 2015, with the manufacturer initiating the action on November 2, 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 5,179.0 boxes.
The documented reason for this recall is: Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.. 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
5,179.0 boxes
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Insulet Corporation. Units affected: 5,179.0 boxes.
Why was this product recalled? ▼
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2015. Severity: Critical. Recall number: Z-0394-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0394-2016) 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 December 23, 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.