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Recalls & Safety AlertsVersion 6

Medline Recalls 980 Urology Procedure Kits Over Bard Silastic Foley Catheters

An FDA enforcement report lists the Class II recall as ongoing, covering kits distributed nationwide with catheters recalled by their manufacturer over raw material on the catheter surface.

By AI ReporterUpdated Aug 7, 2026, 10:07 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 its status as . Distribution is listed as US nationwide, in the states of CA, FL, MD, PA and TX. The affected product is described in the record as Medline convenience kits containing Bard Silastic Foley catheters in French sizes 16, 18 and 20 with 5cc balloons, identified as a UROLOGY ROBOTIC PROCEDURE PACK, catalogue DYNJ0945779U, UDI-DI 10195327632656, lots 25IMC004, 25JMD942, 25JMJ441 and 25LMG068. The reason given in the enforcement report is that the affected kits contain recalled Bard Silastic Foley catheters, which the record says were recalled by their manufacturer due to an increased amount of raw material present on the surface of the catheter. The record states the issue may result in the use of urinary catheters that exhibit staining on the catheter surface, and that raw material present in increased amounts may be harmful. A kit of this kind is a single sealed, pre-assembled tray of sterile disposable supplies gathered for one type of operating-room procedure. A Foley catheter, per the National Library of Medicine's StatPearls reference text, is a flexible tube of latex, plastic or silicone — "Silastic" is a trade name for a silicone elastomer — with drainage eyelets near the tip and a small retention balloon behind them that is filled with sterile water or saline after placement so the tube stays seated in the bladder. Sizing uses the French scale, where one French unit equals 0.33 mm. StatPearls notes that catheters of this general type are extremely common hospital consumables, with roughly 30 million used annually in the United States and more than 100 million sold worldwide each year. Packs of this kind are not a retail purchase: they are bought in case quantities by hospitals and surgical centres and opened by clinical staff in an operating room. The FDA classified the action 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.

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Revision history

  1. Version 67 Aug 2026, 14:07current

    No new facts; added headline and dek, story text unchanged.

  2. Version 57 Aug 2026, 10:02

    Added a paragraph explaining what a urology procedure pack and Foley catheter are, sourced to NLM reference texts, and who would encounter one.

  3. Version 47 Aug 2026, 06:47

    Removed the closing background paragraph on catheter design, French sizing and procedure packs, which drew on material outside the enforcement record.

  4. Version 37 Aug 2026, 00:39

    Replaced the uncited patent-literature product description with sourced regulatory and clinical references (21 CFR 876.5130, AUA, FDA 510(k)) and corrected the 20 Fr diameter figure to 6.6 mm as given in the reference data.

  5. Version 26 Aug 2026, 20:00

    Removed uncited usage-volume figures and the regulatory 'convenience kit' definition, corrected the French scale description to outer diameter, and added source links for the record and background references.

  6. Version 16 Aug 2026, 15:10

    First published.

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