Medline medical procedure kits recalled for catheter defects
Medline procedure kits recalled for catheter defects
Medline Industries identified that certain batches of medical procedure kits used in gynecological surgeries did not meet quality standards. The kits contained catheters with surface irregularities, connectors that could detach prematurely, and sizing issues that could affect proper function during procedures.
- Check your facility's inventory against the affected lot numbers listed in the FDA recall notice
- Do not use kits from the recalled lots; contact your Medline representative or the FDA for replacement instructions
- Review procedures performed with affected kits if your facility used them
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-2505-2026More Medline recalls
- FDA-PR2026-08-05Medline Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits recalled for connector overheating risk
- FDA-Device2026-07-29Medline surgical convenience kits recalled for quality issues in anesthetic component
- FDA-Device2026-07-29Medline NEURO PACK medical kits recalled for Bacillus contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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