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Recalls & Safety AlertsVersion 6

FDA Records Class II Recall of 980 Medline Catheter Kits

An FDA enforcement report filed under recall number Z-2782-2026 lists 980 Medline convenience kits containing Bard Silastic Foley catheters, with the recall status ongoing.

By AI ReporterUpdated Aug 7, 2026, 10:39 a.m. ET
The U.S. Food and Drug Administration has recorded a recall of 980 Medline convenience kits containing Bard Silastic Foley catheters, according to the FDA enforcement report filed under recall number . The record names the firm as , gives an initiation date of 8 June 2026 and a report date of 29 July 2026, and lists the recall status as . The enforcement 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 "NON MB DAVINCI LITHOTOMY SM PK", catalogue code DYNJT6105, UDI-DI 10198459539381, lots 25JBM474 and 25LBS203. Distribution is listed as US nationwide and in the states of CA, FL, MD, PA and TX. The stated reason is that the affected kits contain recalled Bard Silastic Foley catheters, which the record says were recalled by the 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. 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. On what the product is: background reference material describes such a kit as a pre-assembled, single-use sterile procedure tray whose main component is a Foley catheter — a flexible tube placed into the bladder through the urethra. As described by UroToday, an indwelling catheter of this type has two lengthwise channels: one carries urine out to a drainage bag, while the other connects to a small balloon at the tip, filled with sterile water once inside the bladder so the tube stays in place — here a 5 cc balloon. The shaft in this version is a silicone-type elastomer tube, and diameter is given in French units, so sizes 16, 18 and 20 Fr describe progressively wider tubes. The remaining kit contents are the disposable items packaged for a procedure carried out with the patient in the lithotomy position. These are not retail items. The same reference material describes them as hospital and clinic supplies — sterile, single-use kits ordered by the case through medical-supply distribution and opened by clinical staff at the point of care. An ordinary shopper would not buy one off a shelf; those affected are healthcare facilities and their patients.

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Revision history

  1. Version 67 Aug 2026, 14:39current

    No new facts in the record; headline and dek tightened and the enforcement report re-cited as the source of every figure.

  2. Version 57 Aug 2026, 09:39

    Replaced the uncited FDA guidance and 21 CFR product descriptions with the supplied UroToday reference material, attributed as background research.

  3. Version 47 Aug 2026, 06:44

    Replaced the paraphrased product explainer with the FDA's and 21 CFR 876.5130's own definitions and split it into two paragraphs; added the regulatory source URLs to citations.

  4. Version 37 Aug 2026, 00:42current

    Removed unsourced product descriptions (Silastic silicone trade-name gloss, French-scale millimetre conversion) and rewrote the explainer using the cited FDA and eCFR reference material; added source URLs.

  5. Version 26 Aug 2026, 20:04

    Rewrote the product-explainer paragraph to rest only on the supplied reference sources, removing unsourced regulatory and trademark detail, and tightened the opening.

  6. Version 16 Aug 2026, 15:18

    First published.

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