Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DeRoyal(R) Dolphin Inflation Device Recalled by DeRoyal Industries Inc Due to Lack of sterility assurance. There is a defect...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DeRoyal Industries Inc directly.
Affected Products
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.
Quantity: 426 units
Why Was This Recalled?
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About DeRoyal Industries Inc
DeRoyal Industries Inc has 225 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report