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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98586

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 12, 2026
Product types
Device
Classifications
Class I
Statuses
Ongoing
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

1 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 1

Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7

Z-1797-2026
Recall number
Z-1797-2026
Initiated
March 12, 2026
Classification
Class I
Status
Ongoing
Recalling firm
Insulet Corporation
Quantity
1,240,115 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the device defect, the duration of Pod use, and the size of the tear.

Code information

Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7. UDI-DI: 10385083000527. Lot Codes: PH1U02252541, PH1U03282511, PH1U03282522, PH1U03312511, PH1U03312521, PH1U04012511, PH1U04012521, PH1U05052511, PH1U08162531, PH1U08182531, PH1U08182541, PH1U09242511, PH1U09242521, PH1U09242531, PH1U09252521, PH1U09252531, PH1U10152541, PH1U10162531, PH1U10162541, PH1U10172531, PH1U10172541, PH1U10182531, PH1U10182541, PH1U10202511, PH1U10202521, PH1U10202531, PH1U10202541, PH1U10212531, PH1U10212541, PH1U10222531, PH1U10222541, PH1U10232531, PH1U10232541, PH1U10242521, PH1U10242531, PH1U10242541.

Distribution pattern

Nationwide distribution.