FDA Medical devices recall ·
Dentsply Sirona Capsule Mixer Model No recall
- Recall number
- Z-2954-2026
- Date
- (initiated July 20, 2026)
- Company / brand
- SDI Limited
3-15 Brunsdon St, Bayswater, Australia - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,444 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Dentsply Sirona Capsule Mixer Model No. 5546068
Why was it recalled?
Potential for electrical discharge from unit when unplugged.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI:9336472005542; Serial Numbers 0003-1533
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
States: Alaska Arkansas Arizona California Connecticut Florida Georgia Iowa Illinois Kansas Kentucky Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Nevada New York Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2954-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.