Recall Z-2954-2026 ยท EFD Amalgamator, Dental, Ac-Powered
SDI Limited
Dentsply Sirona Capsule Mixer Model No. 5546068
| Date | Aug 14, 2026 (initiated Jul 20, 2026) |
| Status | Open, Classified |
| Reason | Potential for electrical discharge from unit when unplugged. |
| Root cause | Device Design |
| Action | 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.