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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

G & H Wire Company: Latex Orthodontic Elastics Recalled for Mislabeling as Non-Latex

Agency Publication Date: February 2, 2024
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Summary

G & H Wire Company has recalled 81 packs of FLEXSelect 5/16" Amber Latex Elastics because they were incorrectly labeled as non-latex. These elastic bands are used for orthodontic purposes such as braces and closing tooth gaps. Consumers who have a latex allergy could experience a serious allergic reaction if they use these bands, which contain natural rubber latex despite the label indicating otherwise.

Risk

Patients with latex sensitivities or allergies may experience an allergic reaction ranging from skin irritation to anaphylaxis when these bands come into contact with the mouth. No specific injuries have been reported to date, but the mislabeling creates a high risk for those specifically seeking non-latex alternatives.

What You Should Do

  1. Check your orthodontic elastic packaging for 'FLEXSelect 5/16" Amber Latex Elastics' with Ref: AMD56.
  2. Identify if your product is affected by looking for Lot Number 1120035 and UDI 10195291042642 on the label.
  3. If you have a latex allergy or sensitivity, stop using these elastic bands immediately as they contain latex despite being labeled as 'non-latex'.
  4. Contact your orthodontist, healthcare provider, or G & H Wire Company at 1-888-463-6332 to discuss the recall and obtain a safe replacement product.
  5. For additional questions, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Medical Consultation and Replacement

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: FLEXSelect 5/16" Amber Latex Elastics (100/pk)
Model / REF:
AMD56
Lot Numbers:
1120035

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93810
Status: Active
Manufacturer: G & H Wire Company
Sold By: Orthodontic clinics; Dental supply distributors
Manufactured In: United States
Units Affected: 81 pk (100/pk)
Distributed To: Utah, Missouri, West Virginia, Texas, New Jersey

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.