Medline intermittent latex catheter recalled for connector detachment and surface defects
What this means
Medline identified quality issues in its 14 Fr intermittent latex catheter with pre-connected collection bag. Problems include rough spots on the catheter surface, connectors that may detach prematurely, and some catheters that don't meet size specifications.
- Stop using the catheter if you have product number URO4RR14C
- Contact your healthcare provider or Medline for a replacement or alternative
- Check the product number on your catheter packaging to confirm if it is affected
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-2483-2026More 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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