Medline gynecological procedure kits recalled for catheter defects
What this means
Medline identified that samples of its medical procedure kits did not meet quality standards. The catheter components had surface irregularities, connectors that detached prematurely, and in some cases incorrect outer diameters.
- Check your facility's inventory against the affected lot numbers listed in the recall notice.
- Contact Medline with questions about your specific lot numbers.
- Follow Medline's guidance on quarantine or replacement of affected kits.
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-2503-2026More 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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