FDA Medical devices recall ·
DuraMax Chronic Hemodialysis Catheter recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1578-2026
- Date
- (initiated February 13, 2026)
- Company / brand
- Merit Medical Systems, Inc.
1600 W Merit Pkwy, South Jordan, UT, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 21,591
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF:UDI-DI/Lot: H787103028015/A:00884450794524/I3049562; H787103028025/A:00884450794531I3309371; H787103028031/A:00884450794548/I2929299, I3072553, I3154760, I3175731, I3178921, I3315957; H787103028035/A:00884450786130/I2910259, I2910261, I2910262, I2980545, I2995795, I3021388, I3076851, I3085062, I3219446, I3219454, I3255314, I3288649, I3334618; H787103028041/A:00884450794555/I2909647, I3115465, I3178909, I3236154; H787103028045/A:00884450786161/I3004072, I3015761, I3044845, I3072554, I3108153, I3176646, I3178918, I3213147, I3219456, I3281054, I3334627; H787103028051/A:00884450794562/I2995730, I3072556, I3213145, I3219455, I3288560, I3302443; H787103028055/A:00884450794579/I3178903); H787103028061/A:00884450794586/I2929300, I2995814, I3072557, I3165105, I3207168, I3236155, I3334619; H787103028075/A:00884450794609/I2995817), I3209313, I3270826; H787103028085/A:00884450794623/I2890956, I3072561, I3108155, I3288562, I3302444; H787103028095/A:00884450794630/I2909667, I2929315, I3021151, I3098576), I3219463, I3288581; H787103028165/A:00884450794647/I3049563; H787103028181/A:00884450794661/I2929317, I3178900, I3208675; H787103028185/A:00884450786178/I2927170, I2929318, I2929319, I3002050, I3015762, I3021450, I3049572, I3085060, I3173615, I3178896, I3195157; H787103028191/A:00884450794678/I2909758; H787103028195/A:00884450786185/I2890957, I2929321, I3021395, I3049573, I3076853, I3124837, I3169030, I3213148, I3236141, I3236161, I3302447, I3343042; H787103028205/A:00884450794692/I292
Distribution
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
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina Tennessee Texas Utah Virginia Washington Wisconsin West Virginia
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1578-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.