Dentsply Sirona Capsule Mixer Recall Over Electrical Discharge Risk
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
SDI Limited is recalling 1,444 Dentsply Sirona Capsule Mixer units due to potential electrical discharge when unplugged.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 10, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Potential for electrical discharge from unit when unplugged.", distributed 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. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
SDI Limited initiated a voluntary recall of the Dentsply Sirona Capsule Mixer after identifying a potential for electrical discharge from the unit when unplugged.
Which Products Are Affected
The recall involves the Dentsply Sirona Capsule Mixer, Model No. 5546068. Affected units total 1,444 and carry UDI 9336472005542 with serial numbers 0003-1533. The products were distributed across all US states.
What You Should Do
Consumers should contact the recalling firm for additional guidance regarding the recalled devices.
Why This Matters
This Class II recall addresses a device defect with the potential for electrical discharge during normal handling.
Source
FDA recall number Z-2954-2026, initiated July 20, 2026.
Original source: FDA Official Notice ↗
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Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (749 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.