Medline medical procedure kits recalled for catheter defects and performance issues
What this means
Medline found that certain medical procedure kits did not meet quality standards during an internal review. The kits contained catheters with surface irregularities, connectors that detached prematurely, and in some cases outer diameters that did not meet specifications.
- Check your kit number and lot number against the recall list (BIOB686, DYNJ83242, DYNJ83242A, DYNJ83242C, DYNJ67486A, DYNJ14052D, DYNJ14052F, DYNJ14053D, DYNJ14053F, and others)
- Contact Medline or your healthcare facility for instructions on returning or replacing the affected kits
- Do not use affected kits for patient care until you confirm your lot number is 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-2497-2026More 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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