Exact FDA event identifier

Event 96959

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

Open FDA event record

Event summary

Timeline bucket: May 15, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: MEDLINE INDUSTRIES, LP - Northfield

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

Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250

Z-1995-2025

Recall number: Z-1995-2025
Initiated: May 15, 2025
Classification: Class II
Status: Ongoing
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 174 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

packaging defect

Sterility assurance reason.sterility_assurance · v1.0.0

packaging defect impacting the outer Tyvec pouch that protects the sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.

Code information

UDI-DI: 10653160995340 (each), 40653160995341 (case); Lot Numbers: 25BBG881, 24KBU973, 24IBK851, 24HBQ012

Distribution pattern

US Nationwide distribution in the state of VA.