C.R. Bard Silastic Foley Catheters Recall

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.

C.R. Bard Inc is recalling 106,160 Silastic Brand Foley Catheters due to stains on the catheter surface.

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

This notice was issued by FDA on June 11, 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, Devices.

What Happened

C.R. Bard Inc initiated a voluntary recall of Silastic Foley Catheters due to stain present on the surface of affected devices.

Which Products Are Affected

The recall covers 106,160 units distributed in AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and Canada. Affected products include:

  • Silastic Brand Foley Catheter 30cc: REF 33416, 33418, 33420, 33422, 33424
  • Silastic Brand Foley Catheter 5cc: REF 33614, 33616, 33618, 33620, 33622, 33624

Specific catalog numbers, UDI codes, and lot numbers are detailed in FDA recall Z-2226-2026. This is a Class II recall.

What You Should Do

Consumers should refer to the recalling firm or FDA for guidance on affected devices.

Why This Matters

The recall involves over 100,000 units distributed across the United States and Canada.

Source

FDA Enforcement Report - Recall Number Z-2226-2026, initiated April 23, 2026 by C.R. Bard Inc.

Original source: FDA Official Notice ↗

All FDA Recalls →

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?
C.R. Bard Inc is recalling 106,160 Silastic Brand Foley Catheters due to stains on the catheter surface.
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.