Reported Apr 1, 2026 · Ongoing

CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/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?

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

Lot codes and dates: 28 of 28 products
Products covered by this recall
# Barcodes Product as published
1 00884450199992 REF:UDI-DI/Lot: CENFP15K/A:00884450199992/H3357122
2 00884450725917 CENFP15K/B:00884450725917/H2797565
3 00884450200001 CENFP17K/A:00884450200001/H2643728, H2644554, H2755843, H2777866, H3357123
4 00884450200018 CENFP19K/A:00884450200018/H2415318, H2466455, H2466456, H2608337, H2632772, H2632921, H2643525, H2643729, H2658246, H2658395, H2663614, H2708827, H2777850, H2817064, H2817066, H2834183, H2834184, H2835774, H2875195, H2892153, H2900496, H2900649, H2918430, H2938756, H2982068, H2998532, H3019164, H3028009, H3089474, H3096774, H3101839, H3110067, H3123035, H3131873, H3139507, H3143969, H3152236, H3328470, H3332131, H3332133, H3357124, H3383280, H3398546
5 00884450200025 CENFP23K/A:00884450200025/H2368055, H2460265, H2543292, H2612929, H2622368, H2623456, H2631340, H2640771, H2663612, H2663613, H2719753, H2812164, H2817069,, H2834179, H2834181, H2847016, H2868174, H2880283, H2897527, H2900497, H2900550,, H2907334, H2911460, H2938761, H2978595, H2990699, H3004608, H3019163, H3049760,, H3049761 H3052479 H3071291 H3075039, H3089475, H3092914, H3096777, H3104588,, H3107507, H3120779, H3131874, H3143970, H3145117, H3191613, H3211721 H3316467,, H3328494, H3332218, H3332219, H3332220, H3351695
6 00884450200056 CENFP27K/A:00884450200056/H2286892, H2480924, H2623453, H2643731, H2643732, H2653626, H2663616, H2777861, H2798003, H2833668, H2834185, H2880284, H2900619, H2907339, H2910719, H2911565, H2978601, H2986646, H2998508, H3004606, H3013812, H3019148, H3096779, H3110068, H3131879, H3143988, H3145119, H3156431, H3357125, H3383281
7 00884450276068 CENFT15K:00884450276068/H2845485,H2907340, H2911505, H2978606, H3004602
8 00884450820766 CENFT15K/D:00884450820766/ H3071303, H3075046, H3116838
9 00884450200063 CENFP31K/A:00884450200063/H2623455, H2643737, H2663617, H3052480, H3071293, H3071294, H3110069, H3113265, H3143998, H3196708, H3328496, H3332421
10 00884450276082 CENFT17K:00884450276082/H2750962, H2755782, H2777600, H3034899, H3059017, H3059018, H3062346
11 00884450295526 CENFT17K/A:00884450295526/H2911456
12 00884450820773 CENFT17K/D:00884450820773/H3139508
13 00884450276105 CENFT19K:00884450276105/H2632775, H2658397, H2709212, H2817067, H2821275, H2835372, H2856854, H2864393S1, H2884659, H2900500, H2907322, H2907349, H2918517, H2933863, H2937909, H2937910, H2978622, H2999167, H3019145, H3034898, H3049764
14 00884450295540 CENFT19K/A:00884450295540/H2907422
15 00884450725993 CENFT19K/B:00884450725993/H2801414
16 00884450820780 CENFT19K/D:00884450820780/H3049766, H3049767, H3071304, H3075050, H3089478, H3126999, H3144001, H3152238, H3156433, H3162590, H3179819, H3196714, H3221338, H3233980, H3239914, H3253651, H3261220, H3283451, H3306069, H3350849, H3357127, H3357128, H3365884, H3372112, H3398547
17 00884450276129 CENFT23K:00884450276129/H2368107, H2657097, H2709213, H2719652, H2783586, H2812165, H2834187, H2834188, H2864382S1, H2870049, H2892155, H2898665, H2900501, H2907365, H2911451, H2911452, H2934395, H2971862, H2986161, H2986162, H2998549, H3007025, H3019139, H3028000
18 00884450295564 CENFT23K/A:00884450295564/H2709157, H2817068, H2911454, H2990794, H3013830, H3019136, H3034895
19 00884450726006 CENFT23K/B:00884450726006/H2801413
20 00884450820797 CENFT23K/D:00884450820797/H3049771, H3049772, H3071305, H3071306, H3145122, H3152240, H3170518, H3196713, H3201956, H3211729, H3221345, H3233987, H3239915, H3249275, H3275167, H3301761, H3306072, H3323733, H3332225, H3342600
Page 1 of 2
Amount recalled: 35,591

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.

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	`00884450199992`	REF:UDI-DI/Lot: CENFP15K/A:00884450199992/H3357122
2	`00884450725917`	CENFP15K/B:00884450725917/H2797565
3	`00884450200001`	CENFP17K/A:00884450200001/H2643728, H2644554, H2755843, H2777866, H3357123
4	`00884450200018`	CENFP19K/A:00884450200018/H2415318, H2466455, H2466456, H2608337, H2632772, H2632921, H2643525, H2643729, H2658246, H2658395, H2663614, H2708827, H2777850, H2817064, H2817066, H2834183, H2834184, H2835774, H2875195, H2892153, H2900496, H2900649, H2918430, H2938756, H2982068, H2998532, H3019164, H3028009, H3089474, H3096774, H3101839, H3110067, H3123035, H3131873, H3139507, H3143969, H3152236, H3328470, H3332131, H3332133, H3357124, H3383280, H3398546
5	`00884450200025`	CENFP23K/A:00884450200025/H2368055, H2460265, H2543292, H2612929, H2622368, H2623456, H2631340, H2640771, H2663612, H2663613, H2719753, H2812164, H2817069,, H2834179, H2834181, H2847016, H2868174, H2880283, H2897527, H2900497, H2900550,, H2907334, H2911460, H2938761, H2978595, H2990699, H3004608, H3019163, H3049760,, H3049761 H3052479 H3071291 H3075039, H3089475, H3092914, H3096777, H3104588,, H3107507, H3120779, H3131874, H3143970, H3145117, H3191613, H3211721 H3316467,, H3328494, H3332218, H3332219, H3332220, H3351695
6	`00884450200056`	CENFP27K/A:00884450200056/H2286892, H2480924, H2623453, H2643731, H2643732, H2653626, H2663616, H2777861, H2798003, H2833668, H2834185, H2880284, H2900619, H2907339, H2910719, H2911565, H2978601, H2986646, H2998508, H3004606, H3013812, H3019148, H3096779, H3110068, H3131879, H3143988, H3145119, H3156431, H3357125, H3383281
7	`00884450276068`	CENFT15K:00884450276068/H2845485,H2907340, H2911505, H2978606, H3004602
8	`00884450820766`	CENFT15K/D:00884450820766/ H3071303, H3075046, H3116838
9	`00884450200063`	CENFP31K/A:00884450200063/H2623455, H2643737, H2663617, H3052480, H3071293, H3071294, H3110069, H3113265, H3143998, H3196708, H3328496, H3332421
10	`00884450276082`	CENFT17K:00884450276082/H2750962, H2755782, H2777600, H3034899, H3059017, H3059018, H3062346
11	`00884450295526`	CENFT17K/A:00884450295526/H2911456
12	`00884450820773`	CENFT17K/D:00884450820773/H3139508
13	`00884450276105`	CENFT19K:00884450276105/H2632775, H2658397, H2709212, H2817067, H2821275, H2835372, H2856854, H2864393S1, H2884659, H2900500, H2907322, H2907349, H2918517, H2933863, H2937909, H2937910, H2978622, H2999167, H3019145, H3034898, H3049764
14	`00884450295540`	CENFT19K/A:00884450295540/H2907422
15	`00884450725993`	CENFT19K/B:00884450725993/H2801414
16	`00884450820780`	CENFT19K/D:00884450820780/H3049766, H3049767, H3071304, H3075050, H3089478, H3126999, H3144001, H3152238, H3156433, H3162590, H3179819, H3196714, H3221338, H3233980, H3239914, H3253651, H3261220, H3283451, H3306069, H3350849, H3357127, H3357128, H3365884, H3372112, H3398547
17	`00884450276129`	CENFT23K:00884450276129/H2368107, H2657097, H2709213, H2719652, H2783586, H2812165, H2834187, H2834188, H2864382S1, H2870049, H2892155, H2898665, H2900501, H2907365, H2911451, H2911452, H2934395, H2971862, H2986161, H2986162, H2998549, H3007025, H3019139, H3028000
18	`00884450295564`	CENFT23K/A:00884450295564/H2709157, H2817068, H2911454, H2990794, H3013830, H3019136, H3034895
19	`00884450726006`	CENFT23K/B:00884450726006/H2801413
20	`00884450820797`	CENFT23K/D:00884450820797/H3049771, H3049772, H3071305, H3071306, H3145122, H3152240, H3170518, H3196713, H3201956, H3211729, H3221345, H3233987, H3239915, H3249275, H3275167, H3301761, H3306072, H3323733, H3332225, H3342600