FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline Pre-connected Urethral Catheterization Tray recalled for connector detachment and surface defects

OTHERNationwide distribution

Medline urethral catheter tray recalled for connector detachment risk

Medline Industries recalled its Pre-connected Urethral Catheterization Tray (15 Fr, model DYND10407) after finding that some units did not meet quality standards. Problems included rough catheter surfaces, premature separation of the connector from the funnel, and variations in catheter diameter. No injuries have been reported.

  • Check if you have this product (Medline REF DYND10407, all lots affected).
  • Stop using it and contact your healthcare provider or Medline for instructions.
  • Do not discard the tray; return it according to Medline's 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
4304669 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND10407

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2481-2026

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