Medline Convenience Kits Recall Involving Bard Silastic Foley Catheters

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Medline Industries is recalling 980 convenience kits containing Bard Silastic Foley Catheters due to potential surface contamination that may be harmful.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.

What Happened

Medline Industries, LP is recalling certain convenience kits because they contain Bard Silastic Foley Catheters that were previously recalled by the manufacturer. The catheters may have an increased amount of raw material on the surface, which could result in staining and may be harmful.

Which Products Are Affected

The affected product is the Medline convenience kit: NON MB DAVINCI LITHOTOMY SM PK (DYNJT6105) containing Bard Silastic Foley Catheters in French sizes 16, 18, and 20 with 5cc balloons. A total of 980 kits are affected. The kits have UDI-DI 10198459539381 and lot numbers 25JBM474 and 25LBS203. Distribution was limited to California, Florida, Maryland, Pennsylvania, and Texas.

What You Should Do

Consumers should stop using the affected kits and contact Medline Industries for return or refund instructions. The recall was initiated voluntarily by the firm via letter on June 8, 2026.

Why This Matters

The recall addresses a Class II device issue that could lead to use of urinary catheters with potentially harmful surface material.

Source

FDA recall number Z-2782-2026, event ID 99301.

Original source: FDA Official Notice ↗

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Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries is recalling 980 convenience kits containing Bard Silastic Foley Catheters due to potential surface contamination that may be harmful.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.