FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: 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.
- Recall number
- Z-2639-2017
- Recalling firm
- DeRoyal Industries Inc
- 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.
- Status
- Terminated
- Initiated
- 2017-06-07
- Posted
- not on file
- Terminated
- 2020-07-22
- Reason
- Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
- Root cause
- Unknown/Undetermined by firm
- Action
- DeRoyal issued an Urgent Recall Notice dated June 7, 2017, to all affected customers. The customers were asked to identify the affected products and return the provided notice of return form back to DeRoyal indicating if replacement or credit is requested. Customers with questions were instructed to call 888-938-7828 or email recalls@deroyal.com. For questions regarding this recall call 865-938-7828.
- Quantity
- 426 units
- Distribution
- Nationwide Distribution to MD, NY, and IL
- Lot, serial or model codes
- Lot Number 15125173
- 510(k) numbers
- ["K042449"]
- PMA numbers
- not on file
- Product code
- MAV
- Firm FEI
- 1043214
- Firm city
- Powell
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28