DeRoyal — Class II medical device recall Z-2639-2017
Terminated recall by DeRoyal Industries Inc, reported 2017-07-05, distributed nationwide. Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise th
| Recall number | Z-2639-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2017-06-07 |
| Classified | 2017-06-29 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2020-07-22 |
| Distributed | Nationwide (US) |
| Quantity | 426 units |
| Reason classes | sterility |
| Lot numbers | 15125173 |
| Model numbers | 0185ND |
Product
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
Reason for recall
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
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-2639-2017. 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.