Dentsply Sirona Capsule Mixer Model No. 5546068
SDI Limited · Potential for electrical discharge from unit when unplugged.
Open FDA's page for this record- Cfres ID
- 221283
- Product res number
- Z-2954-2026
- Event date initiated
- 2026-07-20
- Event date posted
- 2026-08-14
- Recall status
- Open, Classified
- Res event number
- 99322
- Product code
- EFD
- Product description
- Dentsply Sirona Capsule Mixer Model No. 5546068
- Code info
- UDI:9336472005542; Serial Numbers 0003-1533
- Firm FEI number
- 3004140838
- Recalling firm
- SDI Limited
- Address 1
- 3-15 Brunsdon St
- City
- Bayswater
- Country
- Australia
- Additional info contact
- Racheal Elliott 302-4224511
- Reason for recall
- Potential for electrical discharge from unit when unplugged.
- Root cause description
- Device Design
- Product quantity
- 1,444 units
- 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
- 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 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.
- Harmonized identifiers (openFDA)
- Device name
- Amalgamator, Dental, Ac-Powered
- Medical specialty description
- Dental
- Regulation number
- 872.3100
- Device class
- 1
- K number
- K791410, K901909, K915847, K780560, K880993, K771901, K891612, K914341, K914340, K891064, K910632, K923974, K991913, K922203, K914339
- Registration number
- 3010864832, 1216602, 3008530360, 3001065024, 3002808149, 9616103, 8044164, 3009496224, 9612352, 3005665377, 3003018722, 3004966444, 3005176727, 3004140838, 2424472, 3014326245, 3014953747, 3006552587, 3009171220, 1410097, 2018957, 1000493628, 9611385, 2244812, 9612300, 2031508, 2024312, 8010908, 3035693034, 2916735, 3008559238, 3003169405
- FEI number
- 1216602, 3008530360, 3001065024, 3002808149, 3010862763, 3009496224, 3005665377, 3003018722, 3004966444, 3005176727, 3004140838, 3002718942, 3014326245, 3014953747, 3006552587, 3009171220, 1410097, 2018957, 1000493628, 3002808289, 2244812, 3002808636, 1000207020, 2024312, 3002806930, 3001708019, 3002088145, 3035693034, 3004150030, 2916735, 3008559238, 3003169405