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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98981

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

Open FDA event record

Event summary

Timeline bucket
April 28, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Mentor Texas LP

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

SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston

Z-2614-2026
Recall number
Z-2614-2026
Initiated
April 28, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Mentor Texas LP
Quantity
1401 syringes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A single lot of expired syringes were distributed due to a distribution system control failure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A single lot of expired syringes were distributed due to a distribution system control failure.

Code information

BD Product Code: 302995 Mentor Product Code: B9604 Sales Unit Box UDI-DI/GTIN code: 30382903029952 Individual Unit UDI-DI/GTIN code: 00382903029952 Lot Number: 8298877

Distribution pattern

U.S.: CA, FL, and PA

Field note

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