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Medline Industries, LP: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE

Medical DevicesSource: FDA (device) · Date: 2026-07-29

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
Recall initiated
2026-06-08
Code info
DYNJ0945779U UDI-DI 10195327632656 Lots 25IMC004 25JMD942 25JMJ441 25LMG068
Product quantity
980 kits
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
99301
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