Dentsply Sirona Capsule Mixer Model No. 5546068

FDA device recall Z-2954-2026 · posted 2026-08-14 · Open, Classified

Recall details

Recalling firm

SDI Limited

Reason for recall

Potential for electrical discharge from unit when unplugged.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

EFD

Quantity affected

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

Date initiated

2026-07-20

Date posted

2026-08-14

Location

Bayswater, Australia