Device recall

Dentsply Sirona Capsule Mixer Model No. 5546068

FDA recall source

Recall number

Z-2954-2026

Event id

99322

Status

Ongoing

FDA classification

Class II

Recalling firm

SDI Limited

Report date

Aug 26, 2026

Initiated

Jul 20, 2026

Center classification date

Aug 14, 2026

Reason

Potential for electrical discharge from unit when unplugged.

Quantity

1,444 units

Code info

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

Voluntary or mandated

Voluntary: Firm initiated

Location

Bayswater, Australia