Recall Z-2954-2026
SDI Limited · initiated July 20, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dentsply Sirona Capsule Mixer Model No. 5546068
Codes / lots: UDI:9336472005542; Serial Numbers 0003-1533
Reason for recall
Potential for electrical discharge from unit when unplugged.
FDA-determined cause: Device Design
Action taken
On July 20, 2026, Dentsply Sirona issued a Urgent Medical Device Recall notice to affected consignees via mail. Dentsply Sirona ask consignees to take the following actions: Users 1. Switch off the unit using the rear power switch before removing the plug from the main socket 2. Avoid immediate contact with the plug pins after unplugging. 3. The users should return their unit to Dentsply Sirona to have a corrective modification installed. Please contact Racheal Elliott at rachael.elliott@dentsplysirona.com. 4. Please ensure that all relevant personnel within your organization are informed of the notice. If you have supplied affected units to another organization, please provide this with a copy of the notification. Dealers: 1.Identify all customers who have received the affected units and immediate forward the accompanying communication to those customers. 2.Ensure that all relevant personnel within your organization are informed of this notice. 3.Complete the dealer reply form provided on pages 2 and 3 and rturn it to Dentsply Sirona. 4. Return the completed form via email to Racheal Elliott at rachael.elliott@dentsplysirona.com.
Details
- Recall number
- Z-2954-2026
- Initiated
- July 20, 2026
- Posted by FDA
- August 14, 2026
- Product code
- EFD – Amalgamator, Dental, Ac-Powered
- Quantity
- 1,444 units
- 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
- Recalling firm
- SDI Limited, Bayswater