Z-2954-2026Class II

Dentsply Sirona Capsule Mixer Model No. 5546068

Name: Z-2954-2026 Dentsply Sirona Capsule Mixer Model No. 5546068
Creator: SDI Limited
Published: 2026-07-20
License: https://open.fda.gov/license/

Sdi Ltd. / initiated 2026-07-20 / Open, Classified / root cause: design

FDA source

SDI Limited began a recall of Dentsply Sirona Capsule Mixer Model No. 5546068 on 2026-07-20. FDA classified it as Class II and gives the reason as "Potential for electrical discharge from unit when unplugged". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2954-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-20
Posted: 2026-08-14
Recalling firm: Sdi Ltd.
Product: Dentsply Sirona Capsule Mixer Model No. 5546068
Product code: EFD Amalgamator, Dental, Ac-Powered
Reason for recall: Potential for electrical discharge from unit when unplugged.
Root cause tag: design
FDA 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 [email protected]. 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 [email protected].
Quantity in commerce: 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
Product codes and lots: UDI:9336472005542; Serial Numbers 0003-1533

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2954-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2954-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14

Product code EFD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)