Medline Pre-connected Urethral Catheterization Tray recalled for connector detachment and surface defects
What this means
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.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2481-2026More Medline recalls
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- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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