Acrobat-i Vacuum Stabilizer System — Class II medical device recall Z-0486-2025
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-0486-2025 |
|---|---|
| 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 | 33,823 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00607567100008 |
| Lot numbers | 3000270713, 3000273182, 3000273547, 3000273843, 3000274876, 3000275435, 3000275771, 3000276109, 3000277072, 3000277221, 3000277309, 3000278665, 3000279303, 3000280827, 3000280868, 3000282181, 3000282794, 3000283482, 3000283754, 3000284390, 3000284723, 3000285664, 3000286549, 3000288696, 3000295186, 3000295912, 3000295949, 3000296552, 3000299042, 3000303149, 3000311956, 3000315868, 3000316146, 3000316208, 3000317517, 3000320073, 3000320077, 3000320660, 3000321414, 3000321642 and 65 more |
| Model numbers | C-OM-10000Z |
Product
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
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-0486-2025. 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.