FDA Recall of CentrosFLO Hemodialysis Catheters Due to Design Defect
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 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.
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 ↗
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 (1,662 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.