DeRoyal CARDIAC CATH SET-UP KIT PGYBK — Class II medical device recall Z-0622-2024
Ongoing recall by DeRoyal Industries Inc, reported 2024-01-03, distributed in VA. Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which
| Recall number | Z-0622-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2023-11-22 |
| Classified | 2023-12-28 |
| Reported by FDA | 2024-01-03 |
| Distributed | VA |
| Quantity | 252 units |
| UPC / GTIN / UDI-DI | 00749756364065 |
| Model numbers | 89-10572 |
Product
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Reason for recall
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
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-0622-2024. 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.