MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-0357-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581

Product Classification:

Class II

Date Initiated: October 23, 2024

Date Posted: November 20, 2024

Recall Number: Z-0357-2025

Event ID: 95628

Reason for Recall:

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.

Status: Ongoing

Product Quantity: 626,305 Total Kits (US only)

Code Information:

UDI-DI: 40195327109784 (Case); 10195327109783 (Ea) Lots: 22FBK384 22GBO520

Distribution Pattern:

US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.

Voluntary or Mandated:

Voluntary: Firm initiated