Class II — G & H Wire Company
| Recalling firm | G&H Wire Company |
|---|---|
| Registered facility | G & H Wire Company (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy |
| Product | FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56 |
| Quantity | 81 pk (100/pk) |
| Distribution | Worldwide - US Nationwide distribution in the states of UT, MO, WV, TX, NJ and the countries of Canada, France, Germany, New Zealand, South Africa, Thailand. |
| Initiated | 2023-12-21 |
| Classified | 2024-02-02 |
| Recall number | Z-0976-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — G & H Wire Company (Z-0976-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93810/
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