Drug & Device Safety Atlas

FDA recall record · openFDA

Dental EZ Group Star Dental Division

2 FDA recalls on record (2024) — 2 device. 2 still ongoing.

0
Class I (most serious)
2
Class II
0
Class III
2
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to sta 2

Recalls

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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