Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
What this means
Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) have been recalled due to increased raw material on the catheter surface. This contamination may cause staining and could potentially be harmful if the catheters are used.
- Stop using affected kits (lot numbers 25KBA955 or 26CBL889, UDI-DI 10195327319182).
- Contact Medline or your healthcare provider for replacement or guidance.
- Do not discard the product; return it to your supplier or Medline.
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-2783-2026More 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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