Dentsply Sirona Capsule Mixer Recalled for Electrical Discharge Risk
SDI Limited is recalling 1,444 Dentsply Sirona Capsule Mixers due to a potential for electrical discharge when the unit is unplugged.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of electrical discharge, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
SDI Limited is recalling 1,444 units of the Dentsply Sirona Capsule Mixer, Model No. 5546068. The recall is due to a potential for electrical discharge from the unit when it is unplugged.
The affected devices are identified by UDI 9336472005542 and serial numbers ranging from 0003 to 1533. The products were distributed to dental practices in 45 U.S. states, including Alaska, Alabama, Arizona, California, and Texas, among others. No international distribution is reported.
Consumers and dental professionals should stop using the affected capsule mixers immediately. They should contact SDI Limited for instructions on how to return the device or obtain a replacement.
The recalled product
- Product
- Dentsply Sirona Capsule Mixer Model No. 5546068
- Manufacturer
- SDI Limited
- Hazard
- Affected units
- 1,444
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI:9336472005542
- Serial Numbers 0003-1533
Distribution
Related recalls
Same hazard · electrical discharge
See all →- HighMass Spectrometer Recalled for Risk of Flame and Electrode Ejection
FDA (Devices) · 2023-10-11
- HighAB Sciex 4500MD Triple Quad Mass Spectrometer Recall Due to Fire Risk
FDA (Devices) · 2023-10-11
Other medical device recalls
- ModerateDRG Sperm Ab ELISA Recalled for Potential False Negative Results
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
Similar recalls
- SeverePreformed Endotracheal Tube Connectors May Disconnect During Medical Use
FDA (Devices) · 2023-07-05
- CriticalEndotracheal Tube Connector Disconnection Recall — FDA Class I
FDA (Devices) · 2023-07-05
- SevereEndotracheal Tubes Recalled Due to Connector Disconnection Risk
FDA (Devices) · 2023-07-05
- HighCenturion Medical Products Recalls CAP Bundle Kits Due to Fluid Droplet Risk
FDA (Devices) · 2019-10-16
- HighCenturion Infusa Port Kit Recalled for Fluid Droplet Risk
FDA (Devices) · 2019-10-16
- SevereEndotracheal Tubes With 15mm Connector Disconnection Recalled Nationwide
FDA (Devices) · 2023-07-05