Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology… — Class II medical device recall Z-1708-2016
Terminated recall by Stryker Sustainability Solutions, reported 2016-06-01, distributed in NY. Mislabeled for size
| Recall number | Z-1708-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2016-04-28 |
| Classified | 2016-05-23 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2016-06-29 |
| Distributed | NY |
| Countries outside the US | CA |
| Quantity | 18 devices |
| Reason classes | labeling |
| Lot numbers | 2555866E, 2561683E |
| Model numbers | 401450, 401877 |
| Expiration dates | 2017-05-06, 2017-05-13 |
Product
Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
Reason for recall
Mislabeled for size
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-1708-2016. 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.