FDA-Device2026-07-29Class IIPROCESSING DEFECT

Medline urology robotic procedure packs recalled for defective Bard Silastic Foley Catheters

OTHERNationwide distribution

Medline urology kits recalled for defective Foley Catheters

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.
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. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2781-2026

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