FDA recall, , Moderate risk
Dentsply Sirona Capsule Mixer
The Dentsply Sirona Capsule Mixer can discharge electricity when unplugged.
Summary by Recall Canary from the FDA notice
What happened
SDI Limited of Bayswater, Australia, recalled the Dentsply Sirona Capsule Mixer Model No. 5546068 because of the potential for electrical discharge from the unit when unplugged. The company began the recall on July 20, 2026, and the FDA added it to the Enforcement Report on August 14, 2026.
The recalled units were distributed in the United States, including Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, and West Virginia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Dentsply Sirona Capsule Mixer
- Model number
- 5546068
- UDI-DI
- 9336472005542
Recall details
- Company began the recall
- Sold in
- 48 states
US: Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia HI Iowa ID Illinois IN Kansas Kentucky Louisiana Massachusetts MD ME Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio OK OR Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia OUS: None
- Company
- SDI LimitedBayswater, Australia
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99322
- Recall number
- Z-2954-2026
- Quantity recalled
- 1,444 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
