FDA-Device2026-07-29Class IIPROCESSING DEFECT

Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination

OTHERNationwide distribution

Medline Foley catheter kits recalled for surface contamination risk

Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) have been recalled because the catheters have an increased amount of raw material on their surface. This contamination may cause staining and could be harmful if the catheters are used.

  • Check if you have the affected kit model DYKMBNDL116I with lot numbers 26ABL226 or 26BBD710.
  • Do not use affected catheters.
  • Contact your healthcare provider or Medline for instructions on obtaining replacement catheters.
  • Report any adverse effects to the FDA MedWatch program.
Hazard

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.

Sold states
US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
Affected count
980 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2779-2026

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