BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating — Class II medical device recall Z-0978-2024
Ongoing recall by Maquet Medical Systems USA, reported 2024-02-14, distributed nationwide. Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach o
| Recall number | Z-0978-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Medical Systems USA, Wayne, NJ, United States |
| Recall initiated | 2024-01-08 |
| Classified | 2024-02-02 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, IT, JP, NL |
| Quantity | 1,090 total |
| Reason classes | microbial contamination, sterility, packaging |
| UPC / GTIN / UDI-DI | 04037691650326 |
| Lot numbers | 3000283239, 3000330438 |
Product
BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Reason for recall
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.
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-0978-2024. 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.