FDA Medical Device Recalls (openFDA)
SDI Limited: Dentsply Sirona Capsule Mixer Model No. 5546068
- Recall number
- Z-2954-2026
- Recalling firm
- SDI Limited
- Product
- Dentsply Sirona Capsule Mixer Model No. 5546068
- Status
- Open, Classified
- Initiated
- 2026-07-20
- Posted
- 2026-08-14
- Terminated
- not on file
- 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 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
- 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
- Lot, serial or model codes
- UDI:9336472005542; Serial Numbers 0003-1533
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EFD
- Firm FEI
- 3004140838
- Firm city
- Bayswater
- Firm state
- not on file
- Firm country
- Australia
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28