Exact FDA event identifier

Event 97700

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

Open FDA event record

Event summary

Timeline bucket: September 25, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: LeMaitre Vascular, 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

Artegraft¿ Collagen Vascular Graft; REF: AG1015;

Z-0289-2026

Recall number: Z-0289-2026
Initiated: September 25, 2025
Classification: Class II
Status: Ongoing
Recalling firm: LeMaitre Vascular, Inc.
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The device was incorrectly packed in the wrong size labeled outer packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device was incorrectly packed in the wrong size labeled outer packaging.

Code information

REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;

Distribution pattern

US distribution to the state of: AR