Dentsply Sirona capsule mixers recalled for electrical discharge risk
Dentsply Sirona and SDI Limited are recalling about 1,444 Capsule Mixers, Model No. 5546068, with serial numbers in the 0003-1533 range. The units can release an electrical discharge when they are unplugged. The notice reports no injuries.
From the FDA notice · Read the official notice ↗
What to do
- Check whether your office or facility has a Dentsply Sirona Capsule Mixer, Model No. 5546068.
- Contact Dentsply Sirona or SDI Limited for instructions, since the notice does not list a specific remedy.
- Follow any guidance from the manufacturer before continuing to use the affected unit.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Dentsply Sirona Capsule Mixer Model No. 5546068
- Sold in
- 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
- Made for
- All ages (0 months and older)
Details
- Units affected
- 1,444 units
- Illnesses reported
- None reported
- Manufactured in
- 3-15 Brunsdon St, Bayswater, Australia
- Classification
- Class II
- Recall number
- Z-2954-2026
In the FDA's words
- Description
- Dentsply Sirona Capsule Mixer Model No. 5546068 Potential for electrical discharge from unit when unplugged. UDI:9336472005542; Serial Numbers 0003-1533 Distribution: 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 Affected quantity: 1,444 units
- Hazard
- Potential for electrical discharge from unit when unplugged.