Dentsply Sirona Capsule Mixer Model No — Class II medical device recall Z-2954-2026
Ongoing recall by SDI Limited, reported 2026-08-26, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Potential for electrical discharge from unit when unplugged.
| Recall number | Z-2954-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SDI Limited, Bayswater, Australia |
| Recall initiated | 2026-07-20 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | 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 |
| Quantity | 1,444 units |
| UPC / GTIN / UDI-DI | 09336472005542 |
| Serial numbers | 0003-1533 |
| Model numbers | 5546068 |
Product
Dentsply Sirona Capsule Mixer Model No. 5546068
Reason for recall
Potential for electrical discharge from unit when unplugged.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2954-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.