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) 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 to patients.

  • Check if you have Medline convenience kits with Bard Silastic Foley Catheters, lot numbers 25JBM474 or 25LBS203, product code DYNJT6105.
  • Stop using affected kits immediately.
  • Contact Medline Industries for return or replacement instructions.
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. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2782-2026

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