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FDA · Medical devices ·

Dentsply Sirona Capsule Mixer Model No. 5546068 recall

SDI Limited recalled Dentsply Sirona Capsule Mixer Model No. 5546068 on August 26, 2026 because of potential for electrical discharge from unit when unplugged. It was sold in 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.

Why it was recalled

Potential for electrical discharge from unit when unplugged.

What's recalled

Dentsply Sirona Capsule Mixer Model No. 5546068

Quantity: 1,444 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
SDI Limited, Bayswater
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
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
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
Status
Ongoing
Recall number
Z-2954-2026
Source
U.S. Food and Drug Administration

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