FDAClass IIAugust 26, 2026

Dentsply Sirona Capsule Mixer recall

Dentsply Sirona Capsule Mixer Model No. 5546068

Why was Dentsply Sirona Capsule Mixer recalled?

Potential for electrical discharge from unit when unplugged.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI:9336472005542; Serial Numbers 0003-1533

Product
Dentsply Sirona Capsule Mixer Model No. 5546068
Recalling firm
SDI Limited
Quantity
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
Recall date
August 26, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls