FDA Device recall Z-2639-2017
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedure…
- FDA Device
- Class II
- terminated
- Published 2017-07-05
On 2017-07-05 the FDA classified a Class II recall of DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedure… by Deroyal Industries, citing lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2639-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-07 |
| Published | 2017-07-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Deroyal Industries |
| Distribution | US |
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
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
Identifiers
| code_info | Lot Number 15125173 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2639-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.