Recall Z-2954-2026— SDI Limited

Name: FDA recall Z-2954-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-20

Class II · Ongoing

Class II FDA medical device recall by SDI Limited, initiated 2026-07-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Dentsply Sirona Capsule Mixer Model No. 5546068. Reason: Potential for electrical discharge from unit when unplugged..

Recalling firm: SDI Limited
Classification: Class II
Status: Ongoing
Initiated: 2026-07-20
Firm location: Bayswater, Australia

Product description

Dentsply Sirona Capsule Mixer Model No. 5546068

Reason for recall

Potential for electrical discharge from unit when unplugged.

Data sourced from openFDA. This site is unofficial and independent of the FDA.