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 dimensions that is more difficult using braces alone.

Recall Insight

This FDA Devices action (record #Z-1164-2021) was formally reported on March 10, 2021, with the manufacturer initiating the action on January 21, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. G & H Wire Company is listed as the recalling firm, operating out of Franklin, IN. Federal records indicate 371 pks of 100 elastics (Domestic 127 pks, Foreign 244 pks) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: 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 ba… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the states of CA, CT, FL, IL, KY, MI, MN, MS, MT, NH, NJ, NY, NC, TN, TX, UT, VT, WA, WV, AR, IL, and the countries of Spain, Netherlands, New Zealand, Germany, Fra…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.