Dentsply Sirona Capsule Mixer Model No. 5546068 recall (SDI Limited)
Medical deviceClass IIOngoing
Summary: SDI Limited is recalling Dentsply Sirona Capsule Mixer Model No. 5546068. Reason: Potential for electrical discharge from unit when unplugged.
What is being recalled
Dentsply Sirona Capsule Mixer Model No. 5546068
Why
Potential for electrical discharge from unit when unplugged.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US: AK AL AR AZ CA CO CT DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV OUS: None (states named: 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, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia)
How to tell if yours is affected
UDI:9336472005542; Serial Numbers 0003-1533
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2954-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 20, 2026 |
| Reported | August 26, 2026 |
| Company | SDI Limited |
| Company location | Bayswater, Australia |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1,444 units |
More recalls from SDI Limited · all medical device recalls · recalls from July 2026