Medline medical procedure kits recalled for catheter defects
What this means
Medline identified that samples of several medical procedure kits did not meet quality specifications. Issues included rough catheter surfaces, connectors that detached prematurely, and catheters with incorrect outer diameters. These kits are used in eye and throat surgical procedures.
- Check if your facility has any of the affected Medline kit SKUs (CDS983775I, CDS983775J, CDS983775K, CDS983775L, CDS983775M, DYNJ84480, DYNJVB1080, or DYNJVB1080A)
- If you have affected kits, verify the lot number against the FDA recall list
- Contact Medline or your hospital procurement team for replacement or instructions
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-2507-2026More 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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