RegWardenFDA facility compliance records
Recall

Class II — SDI Limited

Recalling firmSDI LTD.
Registered facilitySDI LTD. (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonPotential for electrical discharge from unit when unplugged.
ProductDentsply Sirona Capsule Mixer Model No. 5546068
Quantity1,444 units
DistributionUS: 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
Initiated2026-07-20
Classified2026-08-14
Recall numberZ-2954-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-09-07. Verify this recall record at FDA → (opens in a new tab)

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