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December 16, 2008: Class 1 Recall For VIBE Technologies and Nebion Unapproved Medical Devices

Class 1 Recall For VIBE Technologies and Nebion Unapproved Medical Devices – The U.S. Food and Drug Administration (FDA) has announced a Class 1 recall for two unapproved and uncleared medical devices manufactured by VIBE Technologies of Greeley, CO, and Nebion, LLC of Los Angeles, CA.

Both manufacturers made claims that their products treated serious and life-threatening illnesses, including cancer, depression, infections, migraines, arthritis, and ruptured discs. Neither company had submitted an application to the FDA for clinical trials that would demonstrate that these products safely and effectively treated these conditions.

Subject to recall are:

• Vibrational Integrated Bio-photonic Energizer (VIBE device); manufactured by VIBE Technologies and claims to treat cancer, infections, and depression.

• HLX8 device, manufactured by Nebion, LLC, and claims to treat cancer, migraines, arthritis, and ruptured discs.

FDA Class 1 Recall

A Class 1 recall means that there is a reasonable probability that the use of the recalled medical device will cause adverse health consequences or death. In the cases of VIBE Technologies and Nebion, LLC, the FDA is concerned that based on the unapproved health claims made by both companies, patients will not seek approved therapies, resulting in more severe illness or death.

Free Medical Device Lawsuit Case Evaluation

The NJ Personal Injury Law Firm of Eric H. Weinberg has been successfully litigating pharmaceutical drug and medical device cases for over twenty years and has recovered in excess of seven hundred million dollars on behalf of injured persons. If you or a loved one have been injured by a defective medicine or medical device, and you have a question about your legal rights, please call our law firm toll free at 1-877-934-6274.

Reporting Adverse Events to the FDA: Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

• Online: Medwatch Safety Reporting

• Regular Mail: use postage-paid FDA form 3500 available at: and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787

• Fax: (800) FDA-0178

• Phone: (800) FDA-1088

Medical Device and Consumer Product Lawsuit Help

Please visit Talcum Powder Lawsuit and Vaginal Mesh Lawsuit to learn more about our legal service on behalf of those injured by dangerous and defective medical devices and consumer products.

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Contact Weinberg Law Firm. You may also call us 24/7 at our toll free number, 1(877) 934-6274.