Dentsply Sirona Capsule Mixer Recalled for Electrical Discharge Risk
SDI Limited is recalling 1,444 Dentsply Sirona Capsule Mixers due to a potential for electrical discharge when the unit is unplugged.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of electrical discharge, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
SDI Limited is recalling 1,444 units of the Dentsply Sirona Capsule Mixer, Model No. 5546068. The recall is due to a potential for electrical discharge from the unit when it is unplugged.
The affected devices are identified by UDI 9336472005542 and serial numbers ranging from 0003 to 1533. The products were distributed to dental practices in 45 U.S. states, including Alaska, Alabama, Arizona, California, and Texas, among others. No international distribution is reported.
Consumers and dental professionals should stop using the affected capsule mixers immediately. They should contact SDI Limited for instructions on how to return the device or obtain a replacement.
The recalled product
- Product
- Dentsply Sirona Capsule Mixer Model No. 5546068
- Manufacturer
- SDI Limited
- Hazard
- Affected units
- 1,444
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI:9336472005542
- Serial Numbers 0003-1533
Distribution
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