Medline medical procedure kits recalled for catheter defects
What this means
Medline identified that certain surgical procedure kits containing catheters did not meet quality standards. Some kits had catheters with surface irregularities, connectors that could detach prematurely, or catheters that were the wrong size.
- Check if your facility received any of the affected Medline kit SKUs (DYNJ908097, DYNJ908097A–D, DYNJ912029, DYNJ55637B, DYNJ43930A, DYNJ67767, DYNJ61136F, DYNJV0172Q, or DYNJ86229).
- Do not use affected kits. Contact Medline with your lot numbers for instructions on return or replacement.
- Review any procedures performed with these kits and consult clinical leadership if needed.
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-2508-2026More 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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