SDI recall: Dentsply Sirona Capsule Mixer Model No
SDI Limited is recalling Dentsply Sirona Capsule Mixer Model No – 1,444 units. The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on July 20, 2026. Distributed in 33 states (Alaska, Arizona, Arkansas, California, Connecticut, Florida, Illinois, Iowa, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin).
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Dentsply Sirona Capsule Mixer Model No |
| Brand | SDI |
| Company | SDI Limited |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 20, 2026 |
| Published by FDA | August 26, 2026 |
| Quantity | 1,444 units |
| Recall ID | 99322 |
Recalled products
- Dentsply Sirona Capsule Mixer Model No. 5546068
- FDA recall number
- Z-2954-2026
- Codes, lots and dates
- UDI:9336472005542; Serial Numbers 0003-1533
- Quantity
- 1,444 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99322
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Bayswater, Australia
Why it was recalled
The reason the FDA lists: “Potential for electrical discharge from unit when unplugged.”
Where it was sold
33 states: Alaska, Arizona, Arkansas, California, Connecticut, Florida, Illinois, Iowa, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin. Distribution as the FDA records it: “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”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99322, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is SDI Dentsply Sirona Capsule Mixer Model No recalled?
Yes. SDI Limited recalled it on July 20, 2026; FDA published it August 26, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Potential for electrical discharge from unit when unplugged.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
In 33 states (Alaska, Arizona, Arkansas, California, Connecticut, Florida, Illinois, Iowa, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin).
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.