FDA Medical Device Recalls (openFDA)
G & H Wire Company: FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
- Recall number
- Z-0976-2024
- Recalling firm
- G & H Wire Company
- Product
- FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
- Status
- Open, Classified
- Initiated
- 2023-12-21
- Posted
- 2024-02-02
- Terminated
- not on file
- Reason
- Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
- Root cause
- Packaging process control
- Action
- 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
- 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.
- Lot, serial or model codes
- UDI: 10195291042642 Lot Number: 1120035
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ECI
- Firm FEI
- 1833132
- Firm city
- Franklin
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28