Merit Maestro Microcatheter — Class II medical device recall Z-0627-2024
Ongoing recall by Merit Medical Systems, Inc., reported 2024-01-10, distributed nationwide. The sterility of microcatheter and infusion system devices cannot be guaranteed.
| Recall number | Z-0627-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2023-11-06 |
| Classified | 2024-01-02 |
| Reported by FDA | 2024-01-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, CH, CN, DE, FR, HK, IT, MX, NL |
| Quantity | 717 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00884450038383, 00884450324592, 00884450335215, 00884450335239, 00884450335246, 00884450335253, 00884450335260, 00884450335277, 00884450335284, 00884450335291, 00884450357903, 00884450357910, 00884450357927, 00884450357934, 00884450357958, 00884450357965, 00884450357989, 00884450358016, 00884450358023, 00884450358030, 00884450358047, 00884450358085, 00884450358139, 00884450358160, 00884450358207 and 5 more |
| Lot numbers | H2747446, H2749336, H2749681, H2750372, H2750378, H2750387, H2750390, H2750484, H2750518, H2750599, H2750697, H2750699, H2750708, H2750714, H2750715, H2750719, H2750721, H2750733, H2750747, H2750756, H2750768, H2752481, H2756603, H2756905, H2758290, H2763805, H2765969, H2765976, H2766010, H2766011, H2766013, H2769214, H2769962, H2769993, H2770003, H2770016, H2770029, H2770087, H2775120, H2775121 and 4 more |
| Model 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-W/A, 28MC24130ST/D, 28MC2415045/D, 28MC24150ST/D, 28MC24150ST/F, 28MC28110ST/D, 28MC2813045/D, 28MC28130SN/D, 28MC28130SN/F, 28MC28130ST/D, 28MC28150SN/D and 6 more |
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 for recall
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0627-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.