Medline urology robotic procedure packs recalled for defective Bard Silastic Foley Catheters
What this means
Medline convenience kits used in urology robotic procedures contain Bard Silastic Foley Catheters with excess raw material on the catheter surface. This material may cause staining and could potentially harm patients. The catheters were originally recalled by the manufacturer due to this manufacturing defect.
- If you received affected kits (lot numbers 25IMC004, 25JMD942, 25JMJ441, or 25LMG068), do not use them.
- Contact Medline Industries or your facility's medical device coordinator for instructions on returning or replacing the kits.
- Check your facility's inventory of urology robotic procedure packs, especially if located in CA, FL, MD, PA, or TX.
The agency's original wording
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2781-2026More 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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