MEGA 7 — Class II medical device recall Z-0311-2025
Ongoing recall by Datascope Corp., reported 2024-11-13. There is discrepant labeling on the inner and outer packaging of the device.
| Recall number | Z-0311-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Fairfield, NJ, United States |
| Recall initiated | 2024-09-17 |
| Classified | 2024-11-05 |
| Reported by FDA | 2024-11-13 |
| Countries outside the US | DE, ES, FI, GB, HK, IE, IT, LT, MX, NO, NZ, PL, SE, SG |
| Quantity | 160 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10607567107974 |
| Lot numbers | 3000344298 |
| Model numbers | 0295-01, 0684-00 |
Product
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Reason for recall
There is discrepant labeling on the inner and outer packaging of the device.
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-0311-2025. 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.