FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics — Class II medical device recall Z-0976-2024
Ongoing recall by G & H Wire Company, reported 2024-02-14, distributed nationwide. Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex all
| Recall number | Z-0976-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | G & H Wire Company, Franklin, IN, United States |
| Recall initiated | 2023-12-21 |
| Classified | 2024-02-02 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, FR, NZ, TH, ZA |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10195291042642 |
| Lot numbers | 1120035 |
| Model numbers | AMD56 |
Product
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Reason for recall
Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0976-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.