DeRoyal Industries Inc: Medical Device Recall in 2017 - (Recall #: Z-2639-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 7, 2017

Date Posted: July 5, 2017

Recall Number: Z-2639-2017

Event ID: 77519

Reason for Recall:

Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility

Status: Terminated

Product Quantity: 426 units

Code Information:

Lot Number 15125173

Distribution Pattern:

Nationwide Distribution to MD, NY, and IL

Voluntary or Mandated:

Voluntary: Firm initiated