Reported Jan 10, 2024 · Ongoing

Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB,…

Merit Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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?

Merit Maestro Microcatheter
Reference Numbers
- 28MC2111045/B
- 28MC21110ST/B
- 28MC2113045/B
- 28MC21130SN/CNB
- 28MC21130ST/B
- 28MC2115045/B
- 28MC2115045/C
- 28MC21150SN/B
- 28MC21150ST/B
- 28MC2411045/D
- 28MC24110SN/D
- 28MC24110ST/D
- 28MC2413045/D
- 28MC24130SN/F
- 28MC24130ST/D
- 28MC24130ST-W/A
- 28MC2415045/D
- 28MC24150ST/D
- 28MC24150ST/F
- 28MC28110ST/D
- 28MC2813045/D
- 28MC28130SN/D
- 28MC28130SN/F
- 28MC28130ST/D
- 28MC28150SN/D
- 28MC28150SN/F
- 29MC2911045/D
- 29MC29130SN/F
- 29MC29130ST/D
- 29MC29150ST/CNB
- 29MC29150ST/D
- CE 2797
- STERILEEO
- Rx ONLY

Lot codes and dates: 7 of 7 products
Products covered by this recall
Model / number Barcodes Product as published
H2769214 00884450335284 Ref:28MC21150ST/B- Lot # H2750719 - UDI: 00884450335291 Ref:28MC2411045/D- Lot # H2750721 and H2769962 - UDI: 00884450357903 Ref:28MC24110SN/D- Lot # H2750518 - UDI: 00884450357910 Ref:28MC24110ST/D- Lot # H2750733 - UDI: 00884450357927 Ref:28MC2413045/D- Lot # H2766010 - UDI: 00884450357934 Ref:28MC24130SN/F- Lot #
H2750372 00884450358207 Ref:28MC24130ST/D- Lot # H2750747 and H2779460 UDI: 00884450357958 Ref:28MC24130ST-W/A- Lot #
H2777603 00884450324592 Ref:28MC2415045/D- Lot # H2750756, H2766011, H2769993, UDI: 00884450357965 Ref:28MC24150ST/D- Lot # H2750768-UDI: 00884450357989 Ref:28MC24150ST/F- Lot # H2749681-UDI: 00884450358245 Ref:28MC28110ST/D- Lot # H2770003- UDI: 00884450358016 Ref:28MC2813045/D- Lot # H2770016- UDI: 00884450358023 Ref:28MC28130SN/D- Lot # H2770029 and H2785162 - UDI: 00884450358030 Ref:28MC28130SN/F- Lot # H2750378 UDI: 00884450358290 Ref:28MC28130ST/D- Lot # H2752481 and H2766013 - UDI: 00884450358047 Ref:28MC28150SN/D- Lot # H2756905 and H2765969 - UDI: Ref:28MC28150SN/F- Lot # H2750387 UDI: 00884450358320 Ref:29MC2911045/D- Lot #
H2758290 00884450358085 Ref:29MC29130SN/F- Lot #
H2750390 00884450358382 Ref:29MC29130ST/D- Lot #
H2750599 00884450358139 Ref:29MC29150ST/CNB- Lot #
H2756603 00884450038383 Ref:29MC29150ST/D- Lot # H2749336,H2765976 and H2770087 - UDI: 00884450358160
Amount recalled: 717 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Nationwide
AL
AZ
CA
CO
CT
FL
IA
IL
IN
KS
MA
MD
MN
MO
NH
NJ
NV
NY
UT
WI

Why it was recalled

The sterility of microcatheter and infusion system devices cannot be guaranteed.

This product could cause temporary or reversible health problems — stop using it.

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

Other recalls from Merit Medical Systems, Inc.

Splashwire Hydrophilic Guide Wire Jun 24, 2026
Philips Bridge Prep Kit May 6, 2026
CentrosFLO Hemodialysis Catheters Apr 1, 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

53 in total.

Where it was distributed

All recall categories · Browse the whole archive

Model / number	Barcodes	Product as published
`H2769214`	`00884450335284`	Ref:28MC21150ST/B- Lot # H2750719 - UDI: 00884450335291 Ref:28MC2411045/D- Lot # H2750721 and H2769962 - UDI: 00884450357903 Ref:28MC24110SN/D- Lot # H2750518 - UDI: 00884450357910 Ref:28MC24110ST/D- Lot # H2750733 - UDI: 00884450357927 Ref:28MC2413045/D- Lot # H2766010 - UDI: 00884450357934 Ref:28MC24130SN/F- Lot #
`H2750372`	`00884450358207`	Ref:28MC24130ST/D- Lot # H2750747 and H2779460 UDI: 00884450357958 Ref:28MC24130ST-W/A- Lot #
`H2777603`	`00884450324592`	Ref:28MC2415045/D- Lot # H2750756, H2766011, H2769993, UDI: 00884450357965 Ref:28MC24150ST/D- Lot # H2750768-UDI: 00884450357989 Ref:28MC24150ST/F- Lot # H2749681-UDI: 00884450358245 Ref:28MC28110ST/D- Lot # H2770003- UDI: 00884450358016 Ref:28MC2813045/D- Lot # H2770016- UDI: 00884450358023 Ref:28MC28130SN/D- Lot # H2770029 and H2785162 - UDI: 00884450358030 Ref:28MC28130SN/F- Lot # H2750378 UDI: 00884450358290 Ref:28MC28130ST/D- Lot # H2752481 and H2766013 - UDI: 00884450358047 Ref:28MC28150SN/D- Lot # H2756905 and H2765969 - UDI: Ref:28MC28150SN/F- Lot # H2750387 UDI: 00884450358320 Ref:29MC2911045/D- Lot #
`H2758290`	`00884450358085`	Ref:29MC29130SN/F- Lot #
`H2750390`	`00884450358382`	Ref:29MC29130ST/D- Lot #
`H2750599`	`00884450358139`	Ref:29MC29150ST/CNB- Lot #
`H2756603`	`00884450038383`	Ref:29MC29150ST/D- Lot # H2749336,H2765976 and H2770087 - UDI: 00884450358160