Medline medical procedure kits recalled for catheter defects
What this means
Medline identified that samples of five medical procedure kit models did not meet quality standards. The kits contained catheters with surface irregularities, connectors that detached prematurely, and diameter measurements outside specifications. These defects could affect proper catheter function during medical procedures.
- Check the kit SKU and lot number against the recalled list
- Contact Medline or your facility's procurement team immediately if you have affected kits
- Do not use recalled kits for patient procedures
- Return unused kits to Medline or your supplier
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-2488-2026More 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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