Z-2639-2017Class II

DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device...

Name: Z-2639-2017 DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device...
Creator: DeRoyal Industries Inc
Published: 2017-06-07
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2017-06-07 / Terminated / root cause: packaging

FDA source

DeRoyal Industries Inc began a recall of DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and... on 2017-06-07. FDA classified it as Class II and gives the reason as "Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2639-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-07
Posted: 2017-06-29
Terminated: 2020-07-22
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.
Product code: MAV Syringe, Balloon Inflation
Reason for recall: Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
Root cause tag: packaging
FDA 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 [email protected]. For questions regarding this recall call 865-938-7828.
Quantity in commerce: 426 units
Distribution: Nationwide Distribution to MD, NY, and IL
Product codes and lots: Lot Number 15125173

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2639-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2639-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29

Product code MAV

K042449Class IIDolphin Inflation DeviceSedat S.A. / cleared 2005-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)