Recall archive / FDA device enforcement
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC211... — FDA record Z-0627-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 6, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- The sterility of microcatheter and infusion system devices cannot be guaranteed.
- Classification
- Class II
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 717 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0627-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Ref:28MC2111045/B - Lot # H2775120 - UDI: 00884450335215; Ref: 28MC21110ST/B- Lot # H2750697 and H2775121 - UDI: 00884450335239; Ref:28MC2113045/B- Lot # H2750699, H2763805, H2775122 - UDI: 00884450335246; Ref:28MC21130SN/CNB- Lot # H2747446-UDI:00884450335253; Ref:28MC21130ST/B- Lot # H2750708 - UDI: 00884450335260 Ref:28MC2115045/B- Lot # H2750484 - UDI: 00884450335277 Ref:28MC2115045/C- Lot # H2750714 - UDI: 00884450442456 Ref:28MC21150SN/B- Lot # H2750715 and 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, MA, MD, MN, MO, NH, NJ, NSW, NV, NY, UT, WI and the countries of Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, Netherlands, Switzerland.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 10, 2024
- Recall initiation date
- Nov 6, 2023
- Center classification date
- Jan 2, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.