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FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline red rubber latex urethral catheters recalled for connector detachment and dimension defects

Medline
OTHERNationwide distribution

Medline urethral catheters recalled for connector detachment risk

Medline identified that samples of their red rubber latex urethral catheters did not meet performance standards. Issues included rough surface finishes, connectors that detached prematurely from the catheter funnel, and some catheters with outer diameters outside specification. This recall affects 11 product sizes distributed worldwide.

  • Check your supply for affected Medline catheter product numbers (DYND13508, DYND13510, DYND13512, DYND13514, DYND13515, DYND13516, DYND13518, DYND13520, DYND13522, DYND13614, DYND13616)
  • Stop using affected catheters immediately
  • Contact your supplier or Medline for instructions on return or replacement
  • Report any injuries or complications to the FDA MedWatch program
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
2237471 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr; 9. DYND13522 - 22 Fr; 10. DYND13614 - 14 Fr; 11. DYND13616 - 16 Fr.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2479-2026

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