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U.S. Department of Health and Human Services

Class 2 Device Recall Dentsply Sirona Capsule Mixer

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 Class 2 Device Recall Dentsply Sirona Capsule Mixersee related information
Date Initiated by FirmJuly 20, 2026
Date PostedAugust 14, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2954-2026
Recall Event ID 99322
Product Classification Amalgamator, dental, ac-powered - Product Code EFD
ProductDentsply Sirona Capsule Mixer Model No. 5546068
Code Information UDI:9336472005542; Serial Numbers 0003-1533
FEI Number 3004140838
Recalling Firm/
Manufacturer		 SDI Limited
3-15 Brunsdon St
Bayswater Australia
For Additional Information ContactRacheal Elliott
302-4224511
Manufacturer Reason
for Recall		Potential for electrical discharge from unit when unplugged.
FDA Determined
Cause 2		Device Design
ActionOn 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.
Quantity in Commerce1,444 units
DistributionUS: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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