Medline urethroplasty procedure kits recalled for catheter defects
What this means
Medline identified quality issues in certain urethroplasty procedure kits during an internal review. The catheters had surface irregularities, connectors that could detach prematurely, and some did not meet size specifications.
- Check if your facility has kits with lot numbers 23DLA834, 23BMC463, 23AMA685, 23AMB905, 22LMG466, 22LMB983, 25JBD225, or 25HBW236.
- Do not use affected kits for urethroplasty procedures.
- Contact your Medline representative or the FDA with questions about your specific lot numbers.
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-2495-2026More 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.