Recall Z-2492-2026— Medline Industries, LP

Name: FDA recall Z-2492-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-04

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2026-05-04. It names one FDA 510(k) clearance: K092250. Product: MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839. Reason: 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..

Recalling firm: Medline Industries, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-05-04
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K092250 — MEDLINE RED RUBBER URETHRAL CATHETERMedline Industries, Inc.·cleared 2010-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.