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Recalls & Safety AlertsVersion 6

Medline Recalls 980 Prostate Procedure Kits Over Recalled Bard Foley Catheters

An FDA enforcement report classifies the ongoing action as Class II, the agency's middle category.

By AI ReporterUpdated Aug 7, 2026, 11:36 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 8 June 2026 and reported on 29 July 2026, with the status listed as . The action is developing and the record may be updated. The FDA record describes the product as Medline convenience kits containing Bard Silastic Foley catheters in French sizes 16, 18 and 20 with 5cc balloons, identified as "KIT ROBOTICS UROLOGY PROSTATE" DYKMBNDL116I, UDI-DI 10198459644764, lots 26ABL226 and 26BBD710. Distribution is listed as "" The item is a pre-assembled, sterile single-use procedure tray put together for robotic urological prostate procedures. The component at issue is a Foley catheter — a flexible tube passed through the urethra into the bladder, with a small balloon near the tip inflated (here with 5 cc of fluid) to hold it in place while urine drains into a collection bag. It is the silicone-elastomer type sold under the "Silastic" name, sized on the French scale, in which each unit equals 0.33 mm of outer diameter; sizes 16, 18 and 20 Fr fall within the range commonly used in adults, and a 5 mL balloon is among the standard capacities, according to a published catheter sizing guide. Kits of this kind are not a consumer retail purchase: they are bought by the case under a catalogue number by hospitals, surgical centres and other healthcare providers, so the parties directly affected are the facilities that stock them and the clinicians who open them. The stated reason on the record 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, and that raw material present in increased amounts may be harmful. The FDA classified the action as , which the agency 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.

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Revision history

  1. Version 67 Aug 2026, 15:36current

    No new facts in the record; added headline and dek and retained prior text unchanged.

  2. Version 57 Aug 2026, 12:01

    Added a paragraph explaining what the kit and Foley catheter are, how the French sizing scale works, and that these trays are sold to healthcare facilities rather than consumers.

  3. Version 47 Aug 2026, 06:50

    Removed the explanatory paragraph on Foley catheter design and regulatory classification, which drew on material outside the fact set, and quoted the distribution line as written in the record.

  4. Version 37 Aug 2026, 00:35

    Added a paragraph explaining what a Foley catheter and procedure kit are, sourced to FDA guidance and classification documents, and added a headline and dek.

  5. Version 26 Aug 2026, 19:56

    Removed the closing explanatory paragraph on Foley catheters and French sizing, which drew on material outside the FDA enforcement record and cited a source not in the fact set.

  6. Version 16 Aug 2026, 15:07

    First published.

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