Sdi Limited: Amalgamator, Dental, Ac-powered

Recall Summary SDI Limited is recalling the Dentsply Sirona Capsule Mixer (Model 5546068), an electrical dental device, because it may discharge electricity when unplugged. The recall affects units distributed across all U.S. states. This is classified as a Class I recall, the most serious category.

Recalling firm
SDI Limited
Product
Dentsply Sirona Capsule Mixer Model No. 5546068
Reason
Potential for electrical discharge from unit when unplugged.
Classification
Class I
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-07-20
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
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

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/0849144f-61bf-4d17-aac9-e92c47a0f1a4