Reported Apr 1, 2026 · Ongoing
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A,…
Merit Medical Systems, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- DuraMax Chronic Hemodialysis Catheter
- REF
H787103028015/AH787103028025/AH787103028031/AH787103028035/AH787103028041/AH787103028045/AH787103028051/AH787103028055/AH787103028061/AH787103028075/AH787103028085/AH787103028095/AH787103028165/AH787103028181/AH787103028185/AH787103028191/AH787103028195/AH787103028205/AH787103028215/AH787103028225/AH787103028235/A
- Lot codes and dates
21 of 21 products
Products covered by this recall # Barcodes Product as published 1 00884450794524REF:UDI-DI/Lot: H787103028015/A:00884450794524/I3049562 2 H787103028025/A:00884450794531I3309371 3 00884450794548H787103028031/A:00884450794548/I2929299, I3072553, I3154760, I3175731, I3178921, I3315957 4 00884450786130H787103028035/A:00884450786130/I2910259, I2910261, I2910262, I2980545, I2995795, I3021388, I3076851, I3085062, I3219446, I3219454, I3255314, I3288649, I3334618 5 00884450794555H787103028041/A:00884450794555/I2909647, I3115465, I3178909, I3236154 6 00884450786161H787103028045/A:00884450786161/I3004072, I3015761, I3044845, I3072554, I3108153, I3176646, I3178918, I3213147, I3219456, I3281054, I3334627 7 00884450794562H787103028051/A:00884450794562/I2995730, I3072556, I3213145, I3219455, I3288560, I3302443 8 00884450794579H787103028055/A:00884450794579/I3178903) 9 00884450794586H787103028061/A:00884450794586/I2929300, I2995814, I3072557, I3165105, I3207168, I3236155, I3334619 10 00884450794609H787103028075/A:00884450794609/I2995817), I3209313, I3270826 11 00884450794623H787103028085/A:00884450794623/I2890956, I3072561, I3108155, I3288562, I3302444 12 00884450794630H787103028095/A:00884450794630/I2909667, I2929315, I3021151, I3098576), I3219463, I3288581 13 00884450794647H787103028165/A:00884450794647/I3049563 14 00884450794661H787103028181/A:00884450794661/I2929317, I3178900, I3208675 15 00884450786178H787103028185/A:00884450786178/I2927170, I2929318, I2929319, I3002050, I3015762, I3021450, I3049572, I3085060, I3173615, I3178896, I3195157 16 00884450794678H787103028191/A:00884450794678/I2909758 17 00884450786185H787103028195/A:00884450786185/I2890957, I2929321, I3021395, I3049573, I3076853, I3124837, I3169030, I3213148, I3236141, I3236161, I3302447, I3343042 18 00884450794692H787103028205/A:00884450794692/I2927146, I2995766, I3015801, I3044846, I3144026, I3219464, I3288564, I3302448 19 00884450794708H787103028215/A:00884450794708/I3178904 20 00884450794715H787103028225/A:00884450794715/I3044836, I3108157, I3236142, I3315958 - Amount recalled
- 21,591
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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