FirstAlerts
Recalls & Safety AlertsVersion 6

FDA Records Class II Recall of 980 Medline Catheter Kits Over Bard Silastic Foley Catheters

The enforcement record cites an increased amount of raw material on the catheter surface; the action is listed as ongoing.

By AI ReporterUpdated Aug 7, 2026, 10:23 a.m. ET
An [FDA enforcement report, recall number ](https://api.fda.gov/food/enforcement.json?search=recall_number:%22Z-2784-2026%22), records an recall of 980 Medline convenience kits containing Bard Silastic Foley catheters in French sizes 16, 18 and 20 with 5cc balloons. The record names the recalling firm as , gives an initiation date of June 8, 2026 and a report date of July 29, 2026, and lists distribution as US nationwide, in the states of CA, FL, MD, PA and TX. The affected product is identified in the record as CDS980523M, UDI-DI 10195327508913, lots 25KBJ177, 25LBO527 and 26ABT761, with the product description marked "ROBOTIC." The action is listed as , and this account reflects the enforcement record as it currently stands. The reason given in the enforcement report is that the affected kits contain recalled Bard Silastic Foley catheters, recalled by the manufacturer due to an increased amount of raw material present on the surface of the catheter. According to the record, the issue may result in the use of urinary catheters that exhibit staining on the catheter surface, and raw material present in increased amounts may be harmful. is the FDA's middle recall category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote, [according to the agency's own definitions](https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions). The FDA's enforcement database records no other enforcement action by this firm. Background on the device, which says nothing about this recall: a Foley catheter is a small, flexible tube passed through the urethra into the bladder so that urine drains continuously into a collection bag, with a balloon behind the tip inflated — here to a 5 cc capacity — to hold it in place, and it is usually inserted and changed by a doctor or nurse, [per StatPearls via the NCBI Bookshelf](https://www.ncbi.nlm.nih.gov/books/NBK564404/). Diameter is given on the French scale, where 1 Fr = 0.33 mm, so sizes 16, 18 and 20 Fr are roughly 5.3, 6.0 and 6.7 mm across. "Silastic" is a trademark registered in 1948 by the Dow Corning Corporation for flexible, chemically inert silicone elastomer used to make or coat catheters of this type, [per Wikipedia](https://en.wikipedia.org/wiki/Silastic); silicone rubber coating of such catheters is described in [US patent 3434869A](https://patents.google.com/patent/US3434869A/en), and catheterization system design in [US patent 8435229B2](https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/8435229). A "convenience kit" means the tube is packaged in one sterile tray with the other items needed for the procedure rather than sold on its own. These are not retail goods: they are finished, sterile-packaged medical devices supplied to hospitals, clinics and other care settings for use by clinicians, assembled and distributed by a medical-supply company rather than by the catheter's own manufacturer. Sources on the device note that more than 100 million urinary catheters are sold worldwide each year, so those affected are healthcare facilities and their patients rather than shoppers.

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Revision history

  1. Version 67 Aug 2026, 14:23current

    No new facts from the record; headline and dek added and opening wording tightened.

  2. Version 57 Aug 2026, 10:22

    Replaced MedlinePlus and WikiDoc device background with StatPearls, Wikipedia and patent sources, added the "ROBOTIC" product coding and the worldwide catheter sales figure.

  3. Version 47 Aug 2026, 06:30

    Replaced the StatPearls-sourced device description and its worldwide/US usage figures with MedlinePlus, Silastic and French-scale references, and added the robotic-surgery kit coding.

  4. Version 37 Aug 2026, 00:57

    Replaced the device-background paragraph with a description sourced to StatPearls/NCBI, dropping the unsourced regulatory citation, trademark history and millimetre conversions, and adding usage-volume figures.

  5. Version 26 Aug 2026, 20:23

    Replaced the product-background paragraph with FDA classification, guidance and 510(k) sourcing plus the Silastic trademark origin, dropping the StatPearls/patent material and its usage statistics, and added a direct link to the enforcement record.

  6. Version 16 Aug 2026, 15:43

    First published.

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