Z-2954-2026Class II

SDI Limited

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

SDI Limited

Product type

Device

Status

Ongoing

Report date

2026-08-26

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

Product quantity

1,444 units

Initiated by

Voluntary: Firm initiated

Reason for recall

Potential for electrical discharge from unit when unplugged.

Product description

Dentsply Sirona Capsule Mixer Model No. 5546068

Code / lot info

UDI:9336472005542; Serial Numbers 0003-1533

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →