FirstAlerts
Recalls & Safety AlertsVersion 6

FDA Records Class II Recall of 980 Medline Prostate Pack Kits Over Bard Foley Catheters

An FDA enforcement report lists an ongoing recall by Medline Industries, LP of convenience kits containing recalled Bard Silastic Foley catheters, distributed in five states.

By AI ReporterUpdated Aug 7, 2026, 10:46 a.m. ET
An FDA enforcement report, recall number , lists an recall by of 980 DAVINCI PROSTATE PACK convenience kits containing Bard Silastic Foley catheters in French sizes 16, 18 and 20 with 5cc balloons. The record gives an initiation date of June 8, 2026 and a report date of July 29, 2026, and lists US nationwide distribution in the states of CA, FL, MD, PA and TX. The affected kits are identified in the record as DYNJ68477L, UDI-DI 10198459487866, lots 25HMF458 and 25LME235; and DYNJ68477M, UDI-DI 10198459678738, lots 26CMK219 and 26EMG622. According to the reason stated in the FDA record, the affected kits contain recalled Bard Silastic Foley catheters, which were recalled by their manufacturer "due to increased amount of raw material present on the surface of the catheter." The record says 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 agency classified the action as . Under the FDA's own definitions, is the middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The action is recorded as , and the enforcement record remains open to updates. The item is not a retail purchase. Background medical reference material describes a hospital procedure kit as a pre-assembled, sterile set of single-use supplies packaged under one catalogue number; the listed component here is a Foley urinary catheter, a flexible silicone tube passed through the urethra into the bladder to drain urine, held in place by a small balloon near the tip that is inflated after insertion — here a balloon of about 5cc capacity. The same reference material notes that French sizes refer to the outside diameter of the tube on the French/Charrière scale, in which 1 French equals one-third of a millimetre, and that sizes 16, 18 and 20 Fr correspond to roughly 5.3, 6.0 and 6.7 mm across. Kits of this kind are ordered by hospitals, operating rooms and other healthcare facilities through medical distributors and handled by clinical staff, so those affected by these codes are hospital purchasing and operating-room personnel rather than shoppers. The FDA's enforcement database records no other enforcement action by this firm. That is context only and says nothing about fault in this action.

Was this report accurate and useful?

Sources

Revision history

  1. Version 67 Aug 2026, 14:46current

    Added a headline and dek, and included the reference material's millimetre equivalents for French sizes 16, 18 and 20.

  2. Version 57 Aug 2026, 10:04

    Removed the unsourced 21 CFR 876.5130 device-classification claim and rewrote the product description to track the cited background reference sources, which are now listed.

  3. Version 47 Aug 2026, 06:46

    Added a paragraph describing what the product is and who handles it, drawn from FDA device regulations and guidance references.

  4. Version 37 Aug 2026, 00:40

    Removed the unsourced explanatory paragraph on convenience kits, Foley catheter regulations and purchasing, which was not supported by the fact set.

  5. Version 26 Aug 2026, 20:01

    Removed the unsupported metric conversion of French sizes, added source URLs and headline/dek, and tightened attribution of the device description to FDA guidance.

  6. Version 16 Aug 2026, 15:17

    First published.

How we work

This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.

Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.

Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.

None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.