Data Foundry

Medical device recalls 2025

Medline UMBILICAL TRAY W/3 — Class II medical device recall Z-1995-2025

Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-07-02, distributed nationwide. There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.

Recall numberZ-1995-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated2025-05-15
Classified2025-06-20
Reported by FDA2025-07-02
DistributedNationwide (US)
Quantity174 units
Reason classessterility, packaging
UPC / GTIN / UDI-DI10653160995340, 40653160995341
Lot numbers24HBQ012, 24IBK851, 24KBU973, 25BBG881
Model numbersUVT1250

Product

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1995-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.