RecallRadar

FDA Device recall Z-2954-2026

Dentsply Sirona Capsule Mixer Model No. 5546068

On 2026-08-26 the FDA classified a Class II recall of Dentsply Sirona Capsule Mixer Model No. 5546068 by Sdi, citing potential for electrical discharge from unit when unplugged.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2954-2026
ClassificationClass II
Statusongoing
Initiated2026-07-20
Published2026-08-26
Last updated2026-09-13 11:58 UTC
CompanySdi
DistributionAK, 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

Product

Dentsply Sirona Capsule Mixer Model No. 5546068

Reason

Potential for electrical discharge from unit when unplugged.

Identifiers

code_infoUDI:9336472005542; Serial Numbers 0003-1533

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2954-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.