Orthodontic Latex Elastics Mislabeled as Non-Latex by Manufacturer
FLEXSelect 5/16" Amber Latex Elastics were labeled as non-latex, creating allergy risk for latex-sensitive patients. Patients with latex allergies should immediately stop using the product.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II allergen mislabeling involving latex, a common allergen. No illnesses or injuries have been reported, placing this under the rubric criterion for allergen mislabeling on common allergens with theoretical risk of harm but no actual injury reports.
Plain-English summary
FLEXSelect 5/16" Amber Latex Elastics (Ref: AMD56) manufactured by G & H Wire Company are being recalled. These orthodontic elastic bands are used in braces for tooth spacing adjustment.
The product contains latex but was labeled as non-latex. This mislabeling creates a serious risk: patients with latex allergies could unknowingly use the product and experience an allergic reaction.
Patients who have known latex allergies should immediately stop using this product if they have purchased it. Contact your orthodontist for a replacement confirmed to be latex-free.
The product was distributed worldwide, including in the United States (Utah, Missouri, West Virginia, Texas, and New Jersey) and internationally in Canada, France, Germany, New Zealand, South Africa, and Thailand. Lot number 1120035 is affected.
The recalled product
- Product
- FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
- Manufacturer
- G & H Wire Company
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 10195291042642 Lot Number: 1120035
Distribution
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