G & H Wire Company Recalls Orthodontic Elastic Bands Due to Labeling Error
G & H Wire Company is recalling orthodontic elastic bands because the patient pack text is incorrect, which could lead to misuse and temporary discomfort.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall for a labeling error that poses a risk of temporary discomfort or misuse, fitting the criteria for a moderate severity recall.
Plain-English summary
G & H Wire Company is recalling 371 packs of 100 orthodontic elastic bands (also known as rubber bands) due to a labeling error on the patient pack. The product itself remains unchanged, and the text on the pack is incorrect. The recall covers specific part numbers (AMD36, AMD56, AMH14, AMH18, AMH36, LFH14, LFH36, LFM14, LFM36) and lot numbers (802028, 811671, 811672, 811673, 813660, 813666, 813669, 822724, 827161, 827172, 827173, 830878, 832605, 835151, 835158).
The recall is precautionary because the incorrect label creates an opportunity for misuse if not read. If a band is too small, the treatment may be more aggressive, and if a small band is applied and breaks, it could result in temporary patient discomfort. The company does not expect device failures. The affected products were distributed worldwide, including in the United States (CA, CT, FL, IL, KY, MI, MN, MS, MT, NH, NJ, NY, NC, TN, TX, UT, VT, WA, WV, AR) and in Spain, Netherlands, New Zealand, Germany, France, Czech Republic, Greece, Poland, Thailand, Belgium, Denmark, United Kingdom, and Canada.
Patients and healthcare providers should check their orthodontic elastic bands for the listed part and lot numbers. If the product matches the recall details, they should stop using it and contact their orthodontist or the recalling firm for instructions.
The recalled product
- Product
- Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any…
- Manufacturer
- G & H Wire Company
- Category
- Medical Device — Orthodontic
- Hazard
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 (20)
- Part Number: AMD36
- AMD56
- AMH14
- AMH18
- AMH36
- LFH14
- LFH36
- LFM14
- LFM36. Lot Number: 802028
- 811671
- 811672
- 811673
- 813660
- 813666
- 813669
- 822724
- 827161
- 827172
- 827173
- 830878
Distribution
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