Medline urethral catheterization trays recalled for connector detachment and diameter defects
What this means
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.
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-2480-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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