Z-2954-2026 Class II Ongoing
FDA device recall Z-2954-2026 was initiated by SDI Limited on July 20, 2026 and is designated Class II. Reason for recall: Potential for electrical discharge from unit when unplugged. The recall status is ongoing. Affected quantity: 1,444 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2026
- Initiation Date
- July 20, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,444 units
Product Description
Dentsply Sirona Capsule Mixer Model No. 5546068
Reason for Recall
Potential for electrical discharge from unit when unplugged.
Distribution Pattern
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
Code Information
UDI:9336472005542; Serial Numbers 0003-1533