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Recalls & Safety AlertsVersion 6

Medline Recalls 980 Urology Kits Containing Recalled Bard Foley Catheters

An FDA enforcement report lists the Class II action as initiated June 8, 2026 and still ongoing.

By AI ReporterUpdated Aug 7, 2026, 10:14 a.m. ET
is recalling 980 convenience kits containing Bard Silastic Foley Catheters, according to an FDA enforcement report filed under recall number . The record lists the recall as initiated on June 8, 2026, reported on July 29, 2026, and still . The record identifies the product as "KIT ROBOTICS UROLOGY PROSTATE," catalogue number DYKMBNDL116G, UDI-DI 10198459156991, lots 25GBG086, 25JBF391, 25KBA114, 25KBN017 and 25LBQ601, containing Foley catheters in French sizes 16, 18 and 20 with 5cc balloons. Distribution is listed in the record as US nationwide and in the states of CA, FL, MD, PA and TX. Background reference material describes the item as a sealed, sterile hospital procedure pack — in the FDA's terms a "convenience kit," defined at 21 CFR 801.3 as two or more different medical devices packaged together for the convenience of the user. The identifying component is the Foley catheter: a soft, flexible tube of elastomeric material with two internal channels, one draining urine and one filling a small retention balloon near the tip (here a 5 cc balloon) so the tube stays seated. Sizes are given on the French, or Charrière, gauge, in which one French unit equals one third of a millimetre. The catheter is passed through the urethra into the bladder and is normally placed by a healthcare provider; the "robotics urology prostate" description indicates a pack assembled for a robot-assisted urological procedure. These are not retail items — they are sold business-to-business to hospitals, surgical centres and clinics, usually through medical distributors, and opened by clinical staff at the point of the procedure. The stated reason is that the affected kits contain recalled Bard Silastic Foley Catheters, which the FDA record says were recalled by the manufacturer "due to increased amount of raw material present on the surface of the catheter." The record adds that the 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." The action is classified . The FDA defines as its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The agency's enforcement database records no other enforcement action by this firm; that history says nothing about fault in this action. The recall remains open.

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Revision history

  1. Version 67 Aug 2026, 14:14current

    Added headline and dek; body unchanged from v5 apart from formatting.

  2. Version 57 Aug 2026, 10:11

    Replaced unsourced product-description details (21 CFR 876.5130 citation, Silastic trademark note, millimetre conversions) with the supplied background reference material and added its source links.

  3. Version 47 Aug 2026, 06:40

    Added a paragraph explaining what a Foley catheter and a convenience kit are and how such kits are distributed, with sourcing to FDA regulations and guidance.

  4. Version 37 Aug 2026, 00:44

    Removed the closing paragraph of general device background, which was not supported by the fact set or the cited records.

  5. Version 26 Aug 2026, 20:09

    Replaced the unsourced CFR/product-code background with sourced NIH StatPearls, catheter-materials review and FDA convenience-kit guidance descriptions, and added those URLs to sources.

  6. Version 16 Aug 2026, 15:23

    First published.

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