FLEXSelect Latex Elastics (G & H Wire) – mislabeling risk (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Brand
G & H Wire Company
Lot Codes / Batch Numbers
UDI: 10195291042642 Lot Number: 1120035
Products Sold
UDI: 10195291042642 Lot Number: 1120035
G & H Wire Company is recalling FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56 due to Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
Recommended Action
Per FDA guidance
G&H Orthodontics issued Product Recall Notice to customers on 12/21/23 via E-mail and phone call. Letter states reason for recall, health risk and action to take: Required Action for Users: Return product for disposal. Follow-up Actions by G&H: Flexmedics intends to replace products with accurately labeled products. You may reach G&H at 1.800.526.1026 or 1.31 7.346.6655 if you have additional questions. We are open 7 AM - 7PM US Eastern Time weekdays
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026