Becton Dickinson Swan-Ganz Catheter Recall

Source: FDA · United States

According to the U.S. Census Bureau's American Community Survey (ACS) 5-year estimates, the CDC PLACES population-level health analysis, and the CMS Hospital Compare quality data, Areazine publishes editorial articles drawing on more than 19,000 U.S. city profiles. See our methodology for full source attribution and refresh cadence.

Becton, Dickinson and Company is recalling 589,223 Swan-Ganz Catheters due to potential leakage or breakage from the proximal injectate lumen hub.

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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Becton, Dickinson and Company is recalling Swan-Ganz Catheters because they may leak or break from the (blue) proximal injectate lumen hub due to manufacturing process and material changes. This may lead to infection, medication loss, and/or blood loss.

Which Products Are Affected

The recall covers Swan-Ganz Catheter models 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, and AIQSGF8. A total of 589,223 units are affected. The recall number is Z-2202-2026. Distribution includes US nationwide and worldwide.

What You Should Do

Consumers should contact Becton, Dickinson and Company regarding the recall. Specific return or refund instructions will be provided by the firm.

Why This Matters

The defect may result in infection, medication loss, or blood loss during use of these catheters.

Source

FDA recall Z-2202-2026 (Class II).

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Becton, Dickinson and Company is recalling 589,223 Swan-Ganz Catheters due to potential leakage or breakage from the proximal injectate lumen hub.
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.