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Dentsply Sirona Capsule Mixer
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MEDICAL DEVICE RECALLMODERATE

Dentsply Sirona Capsule Mixer

Dentsply Sirona Capsule Mixer recalled over electrical discharge risk when unplugged.

What to do

Stop using the affected Capsule Mixer immediately. Contact SDI Limited for instructions on returning the unit or obtaining a replacement. Do not unplug the device while it is connected to a power source.

Recalled
Listed
Updated
Recall No.
Z-2954-2026
Agency
FDA
Firm
SDI Limited
Recall ID
99322
Status
ONGOING

Recall at a glance

Quantity recalled
1,444 units

Why it was recalled

SDI Limited is recalling the Dentsply Sirona Capsule Mixer, Model No. 5546068, because the unit may produce an electrical discharge when unplugged, posing a shock hazard.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Dentsply Sirona Capsule Mixer Model No. 5546068

UDI-DI
9336472005542

Where it was sold

Distributed in 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.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-08-16 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification