FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline urethral catheterization trays recalled for connector detachment and diameter defects

OTHERNationwide distribution

Medline urethral catheterization trays recalled for defects

Medline identified that some urethral catheterization trays (15 Fr size, product numbers DYNC1816 and DYND10350) did not meet quality standards. Problems include irregular catheter surface finish, connectors that may detach prematurely from the catheter funnel, and some catheters with incorrect outer diameter.

  • Check your facility or home supply for the recalled product numbers DYNC1816 or DYND10350.
  • Contact Medline with questions or to report any issues at the number on your product packaging.
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
8327756 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2480-2026

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