Summary
The FDA issued a Class II for Dentsply Sirona Capsule Mixer Model No. 5546068 by SDI Limited. Reason: Potential for electrical discharge from unit when unplugged..
Details
Source
Device Recall
External ID
Z-2954-2026
Action Date
2026-08-26
Status
Ongoing
Category
device
Product Description
Dentsply Sirona Capsule Mixer Model No. 5546068
Lot/Code Info: UDI:9336472005542; Serial Numbers 0003-1533
Quantity Affected: 1,444 units
Reason for Recall
Potential for electrical discharge from unit when unplugged.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-20
Company
Bayswater
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 445 device-related FDA actions this month.
SDI Limited has 4 FDA actions in our database, including 1 recall and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SDI Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SDI Limited have FDA actions?
SDI Limited has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2954-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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