FDA recall Z-2954-2026

SDI Limited · Class II · device

Product

Dentsply Sirona Capsule Mixer Model No. 5546068

Reason for recall

Potential for electrical discharge from unit when unplugged.

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

Key facts

Status
Ongoing
Initiation date
2026-07-20
Report date
2026-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bayswater, Australia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2954-2026