Swan-Ganz Pacing Catheter Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Becton, Dickinson and Company is recalling 53 Swan-Ganz Pacing Catheters due to potential leakage or breakage at 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 Worldwide. 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
Becton, Dickinson and Company initiated a voluntary recall because the catheters may leak or break from the (blue) proximal injectate lumen hub due to manufacturing process and material changes. This could lead to infection, medication loss, and/or blood loss.
Which Products Are Affected
Swan-Ganz Pacing Catheter, Model D200F7. A total of 53 units are affected. The affected lot is identified as D200F7-00690103147315/66725358 (expiration 7/2/2027). Distribution was nationwide in the United States and to numerous countries worldwide.
What You Should Do
Consumers and healthcare providers should follow the recalling firm's instructions regarding the affected devices.
Why This Matters
The Class II recall involves a device distributed across the US and internationally, with potential risks of infection or fluid loss.
Source
FDA recall number Z-2204-2026, event ID 98603. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
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.
Similar body length
Nearest notices by article body length (929 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 11, 2026.
Frequently Asked Questions
Common questions about this FDA recall.