G & H Wire Company
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
Devices registered here (1)
- Bracket, Ceramic, OrthodonticProduct code NJM (opens in a new tab) · Class II · Dental · 21 CFR 872.5470
Recalls & enforcement
- Class IIOngoing2023-12-21Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
- Class IITerminated2021-01-21The 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 …
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “G & H Wire Company (FEI 1833132) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1833132-g-h-wire-company/
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