FDA-Device2026-07-29Class IIPROCESSING DEFECT

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

OTHERNationwide distributionMedical devices

What this means

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 material may cause staining and could potentially be harmful if the catheters are used.

  • Check if you have Medline convenience kit DYNJ61206J (Lot 25IMF461 or 25LMG907).
  • Stop using the affected kit and do not use the catheters.
  • Contact Medline or your healthcare provider for a replacement or guidance.
The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
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. SM-LAPAROSCOPIC PROSTATE PAC DYNJ61206J

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2786-2026

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