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FDA recall, , High risk

Merit Medical Hemodialysis Catheters and Sheath Introducer

Hemodialysis catheters and a sheath introducer may not split as intended.

Summary by Recall Canary from the FDA notice

What happened

Merit Medical Systems, Inc., of South Jordan, Utah, recalled several hemodialysis catheters and a sheath introducer because the 16F dual-valved splittable sheath introducer may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, and loss of vessel for future vascular access.

The recall began February 13, 2026, and was added to the FDA's Enforcement Report on March 26, 2026. Distribution was nationwide and worldwide, including states such as TX, LA, OR, and countries such as Canada, Spain, and Brazil.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. CentrosFLO Hemodialysis Catheters

    Product details from the notice

    CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, 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, CENFT31K/D

    UDI-DI
    • 00884450199992
    • 00884450725917
    • 00884450200001
    • 00884450200018
    • 00884450200025
    • 00884450200056
    • 00884450276068
    • 00884450820766
    • 00884450200063
    • 00884450276082
    • 00884450295526
    • 00884450820773
    • 00884450276105
    • 00884450295540
    • 00884450725993
    • 00884450820780
    • 00884450276129
    • 00884450295564
    • 00884450726006
    • 00884450820797
    • 00884450276143
    • 00884450295588
    • 00884450726013
    • 00884450820803
    • 00884450276167
    • 00884450295601
    • 00884450726020
    • 00884450820810
    Lot code
    • CENFP15K
    • H3357122

  2. ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C

    UDI-DI
    • 00884450697870
    • 00884450697900
    • 00884450697894
    • 00884450697924
    • 00884450697917
    • 00884450697948
    • 00884450697962
    • 00884450697979

  3. 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile)

    UDI-DI
    • 00884450522196
    Reference number
    • FCL-174-00/B
    Lot code
    • FCL-174-00
    • I2362705
    • I2370091
    • I2370711
    • I2370712
    • I2377840
    • I2377841
    • I2391548
    • I2397290
    • I2415120
    • I2417400
    • I2417401
    • I2417402
    • I2428656
    • I2428657
    • I2428658
    • I2428659
    • I2469204
    • I2469205
    • I2469206
    • I2469207
    • I2473119
    • I2485668
    • I2485669
    • I2485670
    • I2485671
    • I2485672
    • I2485673
    • I2485674
    • I2485675
    • I2496785
    • I2496787
    • I2496790
    • I2516610
    • I2516611
    • I2516612
    • I2516613
    • I2516614
    • I2516615
    • I2539710
    • I2539711
    • I2539713
    • I2539714
    • I2539715
    • I2539717
    • I2561078
    • I2561079
    • I2561081
    • I2561082
    • I2573969
    • I2606642
    • I2606643
    • I2606644
    • I2606645
    • I2619459
    • I2621646
    • I2621647
    • I2621648
    • I2621649
    • I2621650
    • I2621651
    • I2621652
    • I2621653
    • I2642738
    • I2642739
    • I2642740
    • I2644031
    • I2644032
    • I2644033
    • I2644034
    • I2644036
    • I2661872
    • I2661873
    • I2661874
    • I2661875
    • I2661876
    • I2661877
    • I2708121
    • I2708122
    • I2708123
    • I2708124
    • I2720071
    • I2720074
    • I2720075
    • I2720076
    • I2720077
    • I2720078
    • I2720079
    • I2729938
    • I2729939
    • I2729940
    • I2729941
    • I2729942
    • I2729943
    • I2729944
    • I2729945
    • I2759253
    • I2759254
    • I2759255
    • I2759256
    • I2759257
    • I2759258
    • I2759260
    • I2759261
    • I2759268
    • I2759269
    • I2781492
    • I2781493
    • I2781494
    • I2781495
    • I2781496
    • I2781497
    • I2781498
    • I2781499
    • I2788883
    • I2788884
    • I2788885
    • I2788886
    • I2788887
    • I2788888
    • I2788889
    • I2788890
    • I2788891
    • I2788892
    • I2810292
    • I2810293
    • I2810294
    • I2810296
    • I2810297
    • I2841474
    • I2841475
    • I2849305
    • I2849306
    • I2854355
    • I2854356
    • I2854357
    • I2860217
    • I2860218
    • I2861568
    • I2861569
    • I2871785
    • I2871786
    • I2871787
    • I2883689
    • I2883691
    • I2890983
    • I2904247
    • I2904250
    • I2927630
    • I2927631
    • I2942563
    • I2942564
    • I2942565
    • I2942566
    • I2942567
    • I2942568
    • I2942569
    • I2942570
    • I2942571
    • I2942667
    • I2942669
    • I2988895
    • I2988896
    • I2988897
    • I3013245
    • I3013246
    • I3075993
    • I3075994
    • I3075995
    • I3075996
    • I3075997
    • I3083308
    • I3083309
    • I3083310
    • I3083312
    • I3083314
    • I3083317
    • I3098214
    • I3098256
    • I3127468
    • I3138237
    • I3138238
    • I3138239
    • I3138240
    • I3138241
    • I3138242
    • I3159773
    • I3159774
    • I3159776
    • I3159777
    • I3186218
    • I3257331

  4. BioFlo DuraMax Catheter

    Product details from the notice

    BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A

    UDI-DI
    • 00884450793206
    • 00884450793213
    • 00884450840733
    • 00884450786215
    • 00884450835326
    • 00884450786253
    • 00884450835333
    • 00884450793220
    • 00884450840740
    • 00884450793237
    • 00884450835340
    • 00884450793244
    • 00884450840757
    • 00884450793251
    • 00884450840764
    • 00884450792353
    • 00884450840771
    • 00884450793268
    • 00884450793282
    • 00884450793299
    • 00884450835371
    • 00884450793305
    • 00884450793312
    • 00884450793329
    • 00884450793336
    • 00884450792360
    • 00884450786314

  5. DuraMax Chronic Hemodialysis Catheter

    Product details from the notice

    DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A

    UDI-DI
    • 00884450794524
    • 00884450794548
    • 00884450786130
    • 00884450794555
    • 00884450786161
    • 00884450794562
    • 00884450794579
    • 00884450794586
    • 00884450794609
    • 00884450794623
    • 00884450794630
    • 00884450794647
    • 00884450794661
    • 00884450786178
    • 00884450794678
    • 00884450786185
    • 00884450794692
    • 00884450794708
    • 00884450794715
    • 00884450842249
    Lot code
    • H787103028015
    • I3049562

Recall details

Company began the recall
Sold in

Worldwide distribution: US (nationwide) to states of: 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 OUS (International) to countries of : Canada, Spain, United Arab Emirates, Brazil, Jordan, Iraq, France, Indonesia, Malaysia, Thailand, Slovakia, Colombia, Saudi Arabia, Belize, Hong Kong, Mexico, Austria, Belgium, Chile, Germany, Sweden, Ireland, Poland, Latvia, Italy, South Africa, Switzerland, Bulgaria, Peru, Argentina, Qatar, Greece, Georgia, United Kingdom, Brunei Darussalam, Ecuador, Panama, Netherlands, Venezuela, Bolivarian Republic of, Costa Rica, Viet Nam, Cayman Islands, Iran, Islamic Republic of, Australia, Nicaragua, Dominican Republic, Bolivia, Plurinational State of, El Salvador, Guatemala, Honduras, Japan

Company
Merit Medical Systems, Inc.South Jordan, Utah
Hazard
Device defect
Risk

High risk

There is a reasonable chance that using it could cause serious health problems or death.

FDA Class I recall · How risk is rated

Event ID
98464
Recall numbers
Z-1575-2026 to Z-1579-2026

All recalls from Merit Medical Systems, Inc.

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

  5. Summary updated

Other device defect recalls

See all: Other device defect recalls

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)