FDA Device recall Z-1995-2025
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
- FDA Device
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250 by Medline Industries Northfield, citing there is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1995-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-15 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Reason
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
Identifiers
| code_info | UDI-DI: 10653160995340 (each), 40653160995341 (case); Lot Numbers: 25BBG881, 24KBU973, 24IBK851, 24HBQ012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1995-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.