Lower risk Medical device recall · FDA · Published January 21, 2021

G & H Wire Company Orthodontic Elastic Bands: Misuse Risk

G & H Wire Company recalls orthodontic elastic bands (AMD36, AMD56, etc.) due to potential misuse risks if label not read, causing discomfort or band breakage.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1164-2021Medical device G & H Wire Company ›

Lower-risk recall

The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the device if the label is not read. If the band is too small, the treatment may be more aggressive. It is important to note that elastic band force decreases over time. If the band is too small and still applied, the band could break. Both circumstances could result in temporary patient discomfort.

Take action

Contact the company

Recalling firmG & H Wire Company2165 Earlywood Dr · Franklin, IN 46131-8879

✎ GovInfoNow plain-language explainer

G & H Wire Company recalls certain orthodontic elastic bands because using them without reading the label may cause the band to break or cause discomfort. This is a misuse risk, not a product defect. Read more at govinfonow.com/recall/63358-g-h-wire-company-orthodontic-elastic-bands-misuse-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63358-g-h-wire-company-orthodontic-elastic-bands-misuse-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1164-2021

Cite this page

“G & H Wire Company Orthodontic Elastic Bands: Misuse Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63358-g-h-wire-company-orthodontic-elastic-bands-misuse-risk. Based on FDA recall #Z-1164-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1164-2021%22&limit=1).

The FDA announced on Jan. 21, 2021, that G & H Wire Company is recalling orthodontic elastics due to a potential for misuse if the label is not read. The recall affects bands with specific part and lot numbers distributed worldwide.

How to tell if you have it

Brand: G & H Wire Company
Product: Band, Elastic, Orthodontic
Part Numbers: AMD36, AMD56, AMH14, AMH18, AMH36, LFH14, LFH36, LFM14, LFM36
Lot Numbers: 802028, 811671, 811672, 811673, 813660, 813666, 813669, 822724, 827161, 827172, 827173, 830878, 832605, 835151, 835158
Quantity: 371 pks of 100 elastics

The hazard

The FDA said the hazard is an opportunity for misuse if the label is not read. If the band is too small, treatment may be more aggressive, and the band could break, resulting in temporary patient discomfort.

Context

GovInfoNow's records show G & H Wire Company has 1 other recall on record since 2023-12-21. On 2023-12-21, the company recalled FLEXSelect 5/16" Amber Latex Elastics due to an allergic reaction risk because they were labeled as non-latex. Other recent recalls of similar products include F & A Foundation Reign Medical Clench Staple System Recall (2026-07-15).

How to tell if you have this one

Check for part numbers AMD36, AMD56, AMH14, AMH18, AMH36, LFH14, LFH36, LFM14, LFM36. Lot numbers include 802028, 811671, 811672, 811673, 813660, 813666, 813669, 822724, 827161, 827172, 827173, 830878, 832605, 835151, 835158.

Brand
G & H Wire Company
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Read the Label
Check the product label to ensure it matches the correct size for your treatment needs.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 20 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of CA, CT, FL, IL, KY, MI, MN, MS, MT, NH, NJ, NY, NC, TN, TX, UT, VT, WA, WV, AR, IL, and the countries of Spain, Netherlands, New Zealand, Germany, France, Czech Republic,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arkansas, California, Connecticut, Florida, Illinois, Kentucky, Michigan, Minnesota, Mississippi, Montana, New Hampshire, New Jersey, New York, North Carolina, Tennessee, Texas, Utah, Vermont, Washington, West Virginia.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

Jan 21, 2021Firm started the recall
Mar 3, 2021FDA classified it Class II
Mar 10, 2021Published in FDA’s Enforcement Report
Sep 20, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63358-g-h-wire-company-orthodontic-elastic-bands-misuse-risk">G &amp; H Wire Company Orthodontic Elastic Bands: Misuse Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1164-2021 (January 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1164-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.