DeRoyal Dolphin Inflation Device Recall: Sterility Risk in Angioplasty Devices
DeRoyal recalls sterile Dolphin Inflation Devices (REF 0185ND) used in angioplasty due to potential sterility compromise in packaging. Affected devices may not be safe for medical use.
Recall notice
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
Contact the company
What happened, in plain English
DeRoyal is recalling sterile Dolphin Inflation Devices used in angioplasty procedures because the packaging may not properly maintain sterility. This could lead to infections if the device is used without being sterile. Read more at govinfonow.com/recall/73918-deroyal-dolphin-inflation-device-recall-sterility-risk-in-angioplasty-devices.
Source Summary by GovInfoNow · govinfonow.com/recall/73918-deroyal-dolphin-inflation-device-recall-sterility-risk-in-angioplasty-devices · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2639-2017
Cite this page
“DeRoyal Dolphin Inflation Device Recall: Sterility Risk in Angioplasty Devices.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73918-deroyal-dolphin-inflation-device-recall-sterility-risk-in-angioplasty-devices. Based on FDA recall #Z-2639-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2639-2017%22&limit=1).
Why it’s dangerous
The device's primary packaging has a defect that may compromise sterility. If the device is not sterile, it could cause infections during medical procedures like angioplasty.
Who’s affected
Healthcare professionals using the device during angioplasty procedures are most at risk. Patients receiving the device for medical treatment could be affected if the device is not sterile.
How to tell if you have this one
Check for the model REF 0185ND on the device. The product was sold with lot number 15125173. This device is used only with a prescription (Rx Only) for angioplasty procedures.
- Brand
DeRoyal- Category
Medical device
What to do — step by step
Check Device Sterility
Verify the device's packaging for any signs of damage or leaks that might indicate sterility compromise.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “Nationwide Distribution to MD, NY, and IL” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, Maryland, New York.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this device used for medical procedures?
Yes, this device is indicated for use during angioplasty procedures to inflate and deflate balloon catheters.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2639-2017 (June 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2639-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.