Medline Convenience Kits Recall Due to 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, LP is recalling 980 convenience kits containing Bard Silastic Foley Catheters distributed to select U.S. states due to potential harmful raw material on catheter surfaces.

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, MedicalDevices.

What Happened Medline Industries, LP initiated a voluntary recall of convenience kits containing Bard Silastic Foley Catheters after the kits were found to include catheters recalled by the manufacturer for an increased amount of raw material on the surface. This issue may result in staining and potential harm from the raw material.

Which Products Are Affected

  • Product: Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons, RR-DAVINCI PROSTATE ACCESSORY, DYNJ63392F
  • UDI-DI: 10198459315572
  • Lots: 25GLA905, 25HLA240, 25HLA894, 25JLA091, 25KLA775, 25LLA985, 26ALA670
  • Quantity: 980 kits
  • Distribution: US Nationwide in CA, FL, MD, PA, and TX
  • Recall Number: Z-2785-2026
  • Classification: Class II

What You Should Do Consumers in possession of the affected kits should discontinue use and contact Medline Industries, LP for further guidance on the ongoing recall.

Why This Matters The recall addresses a potential risk of harm from raw material on urinary catheter surfaces in kits distributed across multiple states.

Source FDA recall Z-2785-2026, Medline Industries, LP, Northfield, IL.

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, LP is recalling 980 convenience kits containing Bard Silastic Foley Catheters distributed to select U.S. states due to potential harmful raw material on catheter surfaces.
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.