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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83502

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

Open FDA event record

Event summary

Timeline bucket
May 16, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Codman & Shurtleff Inc

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

GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).

Z-2280-2019
Recall number
Z-2280-2019
Initiated
May 16, 2019
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff Inc
Quantity
28 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect coil length on the label

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect coil length on the label

Code information

Lot/Serial No: L14364 UDI:10886704080138

Distribution pattern

Japan