Merit Maestro Microcatheter Recall: Sterility Risk in Medical Devices
Merit Medical recalls certain Maestro Microcatheter models due to potential sterility issues. Affected devices may not be sterile, risking infection during medical procedures. Contact Merit Medical for details.
Recall notice
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Contact the company
What happened, in plain English
Merit Medical is recalling specific models of Maestro Microcatheter devices because they may not be sterile. This could lead to infections if used in medical procedures. Affected devices have reference numbers listed in the recall notice. Read more at govinfonow.com/recall/56930-merit-maestro-microcatheter-recall-sterility-risk-in-medical-devices.
Source Summary by GovInfoNow · govinfonow.com/recall/56930-merit-maestro-microcatheter-recall-sterility-risk-in-medical-devices · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0627-2024
Cite this page
“Merit Maestro Microcatheter Recall: Sterility Risk in Medical Devices.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/56930-merit-maestro-microcatheter-recall-sterility-risk-in-medical-devices. Based on FDA recall #Z-0627-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0627-2024%22&limit=1).
Why it’s dangerous
The recall states that the sterility of the microcatheter and infusion system devices cannot be guaranteed. This means the devices might not be sterile, which could lead to infections during medical procedures if used improperly.
Who’s affected
Healthcare professionals and medical facilities that use the Merit Maestro Microcatheter devices are most at risk. Patients using these devices during procedures could face infection risks if the devices are not properly sterile.
How to tell if you have this one
Check the reference numbers on the device: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, and other listed models. The devices are labeled as CE 2797, STERILEEO, Rx ONLY.
- Brand
Merit Medical- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0627-2024 | 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; 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 | 717 units |
| Z-0628-2024 | Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY; Ref:28HC17130SN - Lot# H2769793 - UDI:00884450315453 REF: 28HC17150ST/A - Lot# H2767389 - UDI:00884450358566 REF: 29HC2015045/A - Lot # H2750582 - UDI: 00884450358726 Ref: 29HC20150SN/A - Lot# H2750587 - UDI: 00884450358733 29HC20150ST H2765980 00884450315408 | 59 units |
| Z-0629-2024 | Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY; REF: IS4-135-30 Lot # H2765720 UDI: 00884450000885 REF: IS4-90-10 Lot # H2765603 UDI: 00884450006504 | 3 units |
What to do — step by step
Check Device Reference Numbers
Look for reference numbers such as 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, or 28MC21130SN/CNB on the device packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 20 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Iowa, Kansas, Maryland, Massachusetts, Minnesota, Missouri, Nevada, New Hampshire, New Jersey, New York, Utah, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0627-2024 (November 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0627-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.