MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2025 - (Recall #: Z-1040-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray

Product Classification:

Class II

Date Initiated: November 18, 2024

Date Posted: February 5, 2025

Recall Number: Z-1040-2025

Event ID: 96110

Reason for Recall:

Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.

Status: Ongoing

Product Quantity: 749 units

Code Information:

1) CVI5130: UDI/DI 10653160372349 (each) 00653160372342 (case), Lot Numbers: 2024040490, 2024073190, 2024082790, 2024101790,; 2) STCVC01USGV: UDI/DI 10653160376965 (each) 00653160376968 (case), Lot Numbers: 2024050990.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated