PlainRecordsDentsply Sirona Capsule Mixer Model No…
- Reason
- Potential for electrical discharge from unit when unplugged.
- Status
- Ongoing
- 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
- Enforcement report date
- Aug. 26, 2026
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- SDI Limited
- Product
- Dentsply Sirona Capsule Mixer Model No. 5546068
- Reason
- Potential for electrical discharge from unit when unplugged.
- Distribution pattern
- 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
- Quantity
- 1,444 units
- Codes and lots
- UDI:9336472005542; Serial Numbers 0003-1533
- Recall started
- July 20, 2026
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Amalgamator, Dental, Ac-Powered
- Root cause (FDA)
- Device Design
- What the company told customers
- On July 20, 2026, Dentsply Sirona issued a Urgent Medical Device Recall notice to affected consignees via mail. Dentsply Sirona ask consignees to take the following actions: Users 1. Switch off the unit using the rear power switch before removing the plug from the main socket 2. Avoid immediate contact with the plug pins after unplugging. 3. The users should return their unit to Dentsply Sirona to have a corrective modification installed. Please contact Racheal Elliott at rachael.elliott@dentsplysirona.com. 4. Please ensure that all relevant personnel within your organization are informed of the notice. If you have supplied affected units to another organization, please provide this with a copy of the notification. Dealers: 1.Identify all customers who have received the affected units and immediate forward the accompanying communication to those customers. 2.Ensure that all relevant personnel within your organization are informed of this notice. 3.Complete the dealer reply form provided on pages 2 and 3 and rturn it to Dentsply Sirona. 4. Return the completed form via email to Racheal Elliott at rachael.elliott@dentsplysirona.com.
- Recall number
- Z-2954-2026
What this record is about
A generic icon of the kind of thing the record is about; the record's own words are below. It is not a picture of the product.
“Potential for electrical discharge from unit when unplugged.”Dentsply Sirona Capsule Mixer Model No. 5546068, FDA enforcement report, 2026-08-26. The caption is the record's own words.
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FDA device name: Amalgamator, Dental, Ac-Powered
Distributed in (FDA's record): Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin
This recall among the others
- FDA's enforcement report came 37 days after the firm started the recall. For half of the 860 FDA medical device recall events reported in 2026 so far with a start date, it took 49 days or fewer (by year).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-2954-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-2954-2026, Aug. 26, 2026. "Dentsply Sirona Capsule Mixer Model No." PlainRecords, https://plainrecords.com/recall/device/z-2954-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections