Reported Apr 1, 2026 · Ongoing

BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU,…

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?

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

Lot codes and dates: 27 of 27 products
Products covered by this recall
# Barcodes Product as published
1 00884450793206 REF:UDI-DI/Lot(Expiration): H965103028011/A:00884450793206/I3105589, I3115469, I3314948, I3343030
2 00884450793213 H965103028021/A:00884450793213/I2985084, I3235297, I3302100, I3343023
3 00884450840733 H965103028021/EU:00884450840733/I3254932
4 00884450786215 H965103028031/A:00884450786215/I2890967, I2909607, I2909610, I2909613, I2922255, I2928443, I2928445, I2973185, I2975817, I2979931, I2979932, I3010126, I3015730, I3015731, I3072562, I3108161, I3115487, I3120008, I3156395, I3161825, I3178917, I3202927, I3236144, I3236147, I3236157, I3236162, I3236164, I3368281
5 00884450835326 H965103028031/EU:00884450835326/I3219447, I3270828, I3288591
6 00884450786253 H965103028041/A:00884450786253/I2838431, I2910263, I2910264, I2910265, I2973186, I2975804, I2975805, I2979959, I2979960, I3015758, I3064923, I3064925, I3072563, I3108163, I3120003, I3120006, I3156399, I3165147, I3175748, I3178899, I3208677, I3236145, I3236148, I3236158, I3236163, I3236165, I3312321, I3315961, I3323271, I3347039
7 00884450835333 H965103028041/EU:00884450835333/I3217180, I3270829, I3302439
8 00884450793220 H965103028051/A:00884450793220/I2929337, I2997999, I3311219
9 00884450840740 H965103028051/EU:00884450840740/I3219448, I3270832, I3302440
10 00884450793237 H965103028061/A:00884450793237/I2920321, I2980492, I3154945, I3254911
11 00884450835340 H965103028061/EU:00884450835340/I3196140, I3270833, I3312332
12 00884450793244 H965103028070/A:00884450793244/I3015819, I3113237, I3170179, I3247943, I3288616
13 00884450840757 H965103028070/EU:00884450840757/I3255305, I3307483
14 00884450793251 H965103028080/A:00884450793251/I3002021, I306492, I3178919, I3302450, I3343031
15 00884450840764 H965103028080/EU:00884450840764/I3196137, I3302445, I3334625
16 00884450792353 H965103028090/A:00884450792353/I2920165, I3103138, I3178922, I3290565
17 00884450840771 H965103028090/EU:00884450840771/I3196135, I3302441, I3352493
18 00884450793268 H965103028161/A:00884450793268/I2914680, I2980457), I3098578
19 00884450793282 H965103028181/A:00884450793282/I2890978, I2902665, I2909617, I2909618, I2929338, I3076856, I3085067, I3098579, I3178915, I3254917, I3255301, I3283028
20 00884450793299 H965103028191/A:00884450793299/H2936911, I2870746, I2908636, I2909637, I2910257, I2920337, I2927199, I3144031, I3164176, I3219662, I3236146, I3288655, I3368110
Page 1 of 2
Amount recalled: 47,153

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.

Want the full recall guide?

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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By hazard

Medical device recalls

Other recalls from Merit Medical Systems, Inc.

Splashwire Hydrophilic Guide Wire Jun 24, 2026
Philips Bridge Prep Kit May 6, 2026
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers… Jan 28, 2026
PhD Hemostasis Valve Nov 26, 2025
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42… Sep 17, 2025
High Pressure Tubing Aug 20, 2025

53 in total.

Where it was distributed

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`00884450793206`	REF:UDI-DI/Lot(Expiration): H965103028011/A:00884450793206/I3105589, I3115469, I3314948, I3343030
2	`00884450793213`	H965103028021/A:00884450793213/I2985084, I3235297, I3302100, I3343023
3	`00884450840733`	H965103028021/EU:00884450840733/I3254932
4	`00884450786215`	H965103028031/A:00884450786215/I2890967, I2909607, I2909610, I2909613, I2922255, I2928443, I2928445, I2973185, I2975817, I2979931, I2979932, I3010126, I3015730, I3015731, I3072562, I3108161, I3115487, I3120008, I3156395, I3161825, I3178917, I3202927, I3236144, I3236147, I3236157, I3236162, I3236164, I3368281
5	`00884450835326`	H965103028031/EU:00884450835326/I3219447, I3270828, I3288591
6	`00884450786253`	H965103028041/A:00884450786253/I2838431, I2910263, I2910264, I2910265, I2973186, I2975804, I2975805, I2979959, I2979960, I3015758, I3064923, I3064925, I3072563, I3108163, I3120003, I3120006, I3156399, I3165147, I3175748, I3178899, I3208677, I3236145, I3236148, I3236158, I3236163, I3236165, I3312321, I3315961, I3323271, I3347039
7	`00884450835333`	H965103028041/EU:00884450835333/I3217180, I3270829, I3302439
8	`00884450793220`	H965103028051/A:00884450793220/I2929337, I2997999, I3311219
9	`00884450840740`	H965103028051/EU:00884450840740/I3219448, I3270832, I3302440
10	`00884450793237`	H965103028061/A:00884450793237/I2920321, I2980492, I3154945, I3254911
11	`00884450835340`	H965103028061/EU:00884450835340/I3196140, I3270833, I3312332
12	`00884450793244`	H965103028070/A:00884450793244/I3015819, I3113237, I3170179, I3247943, I3288616
13	`00884450840757`	H965103028070/EU:00884450840757/I3255305, I3307483
14	`00884450793251`	H965103028080/A:00884450793251/I3002021, I306492, I3178919, I3302450, I3343031
15	`00884450840764`	H965103028080/EU:00884450840764/I3196137, I3302445, I3334625
16	`00884450792353`	H965103028090/A:00884450792353/I2920165, I3103138, I3178922, I3290565
17	`00884450840771`	H965103028090/EU:00884450840771/I3196135, I3302441, I3352493
18	`00884450793268`	H965103028161/A:00884450793268/I2914680, I2980457), I3098578
19	`00884450793282`	H965103028181/A:00884450793282/I2890978, I2902665, I2909617, I2909618, I2929338, I3076856, I3085067, I3098579, I3178915, I3254917, I3255301, I3283028
20	`00884450793299`	H965103028191/A:00884450793299/H2936911, I2870746, I2908636, I2909637, I2910257, I2920337, I2927199, I3144031, I3164176, I3219662, I3236146, I3288655, I3368110