Exact FDA event identifier

Event 71651

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: July 13, 2015
Product types: Device
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Insulet Corporation

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-2484-2015

Recall number: Z-2484-2015
Initiated: July 13, 2015
Classification: Class I
Status: Terminated
Recalling firm: Insulet Corporation
Quantity: 24829 boxes Expanded: 26,230.9 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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

Code information

Lot Numbers: L40806, L40811, L40895, L40976, L41014, L41025, L41067, L41162, L41171, L41197, L41198, L41250 Expanded Recall: Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907

Distribution pattern

Worldwide Distribution: US (Nationwide) and country of: Switzerland.

device · product 2 of 2

OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Z-2485-2015

Recall number: Z-2485-2015
Initiated: July 13, 2015
Classification: Class I
Status: Terminated
Recalling firm: Insulet Corporation
Quantity: 16,017 boxes. Expanded Recall: 5,179.0 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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

Code information

Lot Numbers: L40771, L40892, L40901, L40905, L40997, L41199, L41208 Expanded Recall: Lot Codes: L41908, L41910, F41935

Distribution pattern

Worldwide Distribution: US (Nationwide) and country of: Switzerland.