FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline urethral catheterization trays recalled for connector detachment and surface defects

OTHERNationwide distribution

Medline urethral catheter trays recalled for connector detachment risk

Medline found that samples of its 15 Fr urethral catheterization trays did not meet quality standards. Problems included rough spots on the catheter surface, connectors that could detach from the catheter funnel, and catheters with incorrect outer diameter in some cases.

  • Check if you have Medline urethral catheterization trays (Product Number DYND18350) for patient use.
  • Stop using affected trays and quarantine them.
  • Contact Medline or your supplier for replacement or guidance.
Hazard

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.

Sold states
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Affected count
235658 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2482-2026

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