Acrobat SUV Vacuum Stabilizer System — Class II medical device recall Z-0485-2025
Ongoing recall by Maquet Cardiovascular, LLC, reported 2024-11-27, distributed nationwide. Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot
| Recall number | Z-0485-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2024-10-16 |
| Classified | 2024-11-18 |
| Reported by FDA | 2024-11-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BD, BE, BH, CA, CH, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, HK, HR, ID, IN, IT, JP, KR, LB, LU, MY, NL, OM, PK, PL, PT, SI, TR, ZA |
| Quantity | 10,778 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00607567900004 |
| Lot numbers | 3000269996, 3000270477, 3000274130, 3000274640, 3000279333, 3000279342, 3000279839, 3000280059, 3000280563, 3000284660, 3000284695, 3000288445, 3000288446, 3000298982, 3000299814, 3000314838, 3000314841, 3000315179, 3000317739, 3000318197, 3000321412, 3000325025, 3000325028, 3000325362, 3000337154, 3000340964, 3000340989, 3000349055, 3000349295, 3000356063, 3000356305, 3000362853, 3000368568, 3000376711, 3000399170 |
| Model numbers | C-OM-9000Z |
Product
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Reason for recall
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
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-0485-2025. 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.