LINEAR 7 — Class III medical device recall Z-2568-2014
Terminated recall by Datascope Corporation, reported 2014-09-10, distributed in TX. During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 4
| Recall number | Z-2568-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corporation, Fairfield, NJ, United States |
| Recall initiated | 2014-08-11 |
| Classified | 2014-09-03 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2015-02-05 |
| Distributed | TX |
| Reason classes | labeling |
| Model numbers | 0684-00-0480-01U |
Product
LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
Reason for recall
During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.
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-2568-2014. 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.