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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82003

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

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Event summary

Timeline bucket
December 18, 2018
Product types
Device
Classifications
Class II
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

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 DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1

Z-0347-2020
Recall number
Z-0347-2020
Initiated
December 18, 2018
Classification
Class II
Status
Terminated
Recalling firm
Insulet Corporation
Quantity
264

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.

Code information

Lot Numbers L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, L000136

Distribution pattern

US Nationwide.