Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three dimens...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the device if the label is not read. If the band is too small, the treatment may be more aggressive. It is important to note that elastic band force decreases over time. If the band is too small and still applied, the band could break. Both circumstances could result in temporary patient discomfort.
What to do
FDA enforcement status: Terminated
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCConair Recalls Over One Million Cuisinart Grill Brushes Due to Ingestion Hazard2026-07-02
- CPSCNexgrill Recalls Over 10.2 Million Metal Wire Bristle Grill Brushes Due to Ingestion Hazard; Sold at Home Depot2026-03-26
- FDAFLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD562023-12-21
- CPSCSpeeCo Recalls Fence Wire Stretchers Due to Laceration Hazard2016-08-11
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