FDA Device recall Z-2954-2026
Dentsply Sirona Capsule Mixer Model No. 5546068
- FDA Device
- Class II
- ongoing
- Published 2026-08-26
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2954-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-20 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Sdi |
| Distribution | 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 |
Product
Dentsply Sirona Capsule Mixer Model No. 5546068
Reason
Potential for electrical discharge from unit when unplugged.
Identifiers
| code_info | UDI: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
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