Medline 22F Robinson catheter kits recalled for connector detachment and surface defects
What this means
Medline identified manufacturing defects in certain batches of 22F Robinson sterile catheter kits. Some catheters had rough surface finishes, connectors that detached prematurely, or outer diameters that didn't meet specifications. About 1,000 units were affected worldwide.
- Check if you have any of the affected lot numbers: 25JMK709, 25FMJ661, 25CMG042, 24IME549, 24GMD004, 24CMF091, 24CME465, or 24BMH490.
- Do not use affected kits. Contact your supplier or Medline for instructions on return or replacement.
- If a catheter connector detached during use, contact your healthcare provider.
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-2492-2026More Medline recalls
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- 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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