FDA Device recall Z-0976-2024
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
- FDA Device
- Class II
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class II recall of FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56 by G And H Wire, citing latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0976-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-21 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | G And H Wire |
| Distribution | US |
Product
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Reason
Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
Identifiers
| code_info | UDI: 10195291042642 Lot Number: 1120035 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0976-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.