MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350

FDA device recall Z-2482-2026 · posted 2026-06-17 · Open, Classified

Recall details

Recalling firm

Medline Industries, LP

Reason for recall

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

Action taken

Medline Industries issued two URGENT MEDICAL DEVICE RECALL notice on 5/4/2026 to its consignees, one to its catheter and catheter tray consignees, and the other to the kit consignees via USPS and email. Both notices explained the issue and potential risk. The catheter and catheter tray consignees were directed to respond to the notice and destroy the affected products. The kit consignees were directed to respond to the notice and apply additional labeling (over-labels) to affix to the kits which instruct the user to remove and destroy the affected component. Both notices direct distributors or those who further distributing the products to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

OHR

Quantity affected

235658 units

Distribution

Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.

Date initiated

2026-05-04

Date posted

2026-06-17

Location

Northfield, IL