FDA Recall of CentrosFLO Hemodialysis Catheters Due to Design Defect

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.

Merit Medical Systems is recalling 35,591 units of CentrosFLO Hemodialysis Catheters because of a design defect that may prevent proper splitting, potentially leading to serious health risks.

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

This notice was issued by FDA on April 8, 2026 and geographically references United States. Its severity classification of "high" 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 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.

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Recall of CentrosFLO Hemodialysis Catheters

What Happened

The recall is due to a design defect in the 16F dual-valved splittable sheath introducer, which may not split as intended, potentially resulting in hemorrhage, foreign bodies, and procedure delays.

Which Products Are Affected

The affected products include various models of CentrosFLO Hemodialysis Catheters, such as REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, and CENFT31K/D. A total of 35,591 units are affected, with distribution in the United States nationwide to states including TX, LA, OR, NM, MI, FL, CO, CA, GA, NC, AK, NY, PA, WI, NJ, VA, AZ, IN, KY, MO, DE, SC, MT, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR, NV, and internationally to countries such as Canada, Spain, and others. The official recall number is Z-1575-2026.

What You Should Do

Consumers should check if their device matches the affected models and lots, and contact Merit Medical Systems, Inc. at their address: 1600 W Merit Pkwy, South Jordan, UT 84095-2416, for information on returns or refunds related to this voluntary recall.

Why This Matters

This Class I recall highlights a serious risk of adverse health effects, including hemorrhage, which could lead to significant patient harm, underscoring the need for immediate verification and action by users.

Source

FDA Recall: Z-1575-2026 (attribution to FDA)

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Merit Medical Systems is recalling 35,591 units of CentrosFLO Hemodialysis Catheters because of a design defect that may prevent proper splitting, potentially leading to serious health risks.
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 "high" severity. Take precautions and monitor for updates.
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.