Medline medical procedure kits recalled for catheter defects and connector failure risk
What this means
Medline identified quality issues in several medical procedure kits during an internal review. Some catheters had surface irregularities, connectors that detached prematurely, or outer diameters that did not meet specifications. The affected kits include tracheostomy tube inserts, T&A kits, ear packs, and other surgical procedure kits.
- Check the lot number on your medical procedure kit against the FDA recall notice.
- Contact Medline or your healthcare facility if you have an affected kit.
- Do not use affected kits until you have confirmed they are not on the recall list.
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-2491-2026More 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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