SDI Limited: Dentsply Sirona Capsule Mixer Model No. 5546068
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- SDI Limited
- Product
- Dentsply Sirona Capsule Mixer Model No. 5546068
- Reason / hazard
- Potential for electrical discharge from unit when unplugged.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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
- Recall initiated
- 2026-07-20
- Code info
- UDI:9336472005542; Serial Numbers 0003-1533
- Product quantity
- 1,444 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bayswater
- Country
- Australia
- Event id
- 99322
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