FDA recall record · openFDA

Young Dental Manufacturing I, LLC

4 FDA recalls on record (2023–2024) — 4 device. 4 still ongoing.

Class I (most serious)

Class II

Class III

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

The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination. 1

Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032 1

one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup 1

The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum. 1

Recalls

BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solut Class II 2024-08-23 Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse Class II 2024-05-13 CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles Class II 2023-10-06 BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish Class II 2023-05-23

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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