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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/Home Healthcare

Breg Inc: Folding Walkers with Wheels Recalled Due to Misaligned Wheels

Agency Publication Date: November 3, 2023
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Summary

Breg Inc. is recalling 11,193 units of the BREG REF 100519-000 Folding Walker with Wheels because the devices were manufactured with misaligned wheels. This manufacturing defect prevents the walker from meeting its design specifications and may impact its stability or ease of movement during use. Consumers should immediately identify if their walker is part of the affected lot numbers and contact their healthcare provider or the manufacturer for further instructions.

Risk

The misaligned wheels on these walking aids can cause the device to function incorrectly, potentially leading to instability or an increased risk of falls and injuries while the user is walking.

What You Should Do

  1. Check your walker's model number and lot number to see if it is affected. The recall applies to the BREG REF 100519-000 Folding Walker with Wheels with UDI-DI Code 00672736130834.
  2. Identify your lot number on the product label. Affected lot numbers are: CM82293623, CM82293923, CM82293823, CM82442923, CM82457323, CM82457423, CM82442823, CM82457523, CM82531023, and CM82531223.
  3. If your walker matches the model and lot numbers listed above, contact your healthcare provider or Breg Inc. immediately to discuss the defect and obtain further instructions on how to proceed.
  4. Contact the manufacturer, Breg Inc., for guidance on receiving a potential refund or replacement for the defective walker.
  5. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer guidance

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

Affected Products

Product: BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS
Model / REF:
100519-000
UDI-DI Code: 00672736130834
Lot Numbers:
CM82293623
CM82293923
CM82293823
CM82442923
CM82457323
CM82457423
CM82442823
CM82457523
CM82531023
CM82531223

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93114
Status: Active
Manufacturer: Breg Inc
Sold By: Authorized medical device distributors
Manufactured In: United States
Units Affected: 11,193 units
Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming

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.