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CLASS II · ModerateFDA

SDI Limited recalls Dentsply Sirona Capsule Mixer

📅 Jul 20, 2026 · 📍 AK, AL, AR, AZ, CA, CO, CT, DE +40
Recalling company
SDI Limited
Product
Dentsply Sirona Capsule Mixer Model No. 5546068
Reason
Potential for electrical discharge from unit when unplugged.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jul 20, 2026
Reported
Aug 26, 2026
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
Status
Ongoing
Quantity
1,444 units
Lot / codes
UDI:9336472005542; Serial Numbers 0003-1533
Company location
Bayswater
Recall type
Voluntary: Firm initiated
Recall number
Z-2954-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2954-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.