⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

SDI Limited: Dentsply Sirona Capsule Mixer Model No. 5546068

Medical DevicesSource: FDA (device) · Date: 2026-08-26

Read the official notice at FDA (device) →

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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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