Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
All brochures printed before November 20 Recalled by Hyperion Medical Due to Brochures and web site information for the HyperBlue...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hyperion Medical directly.
Affected Products
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.
Quantity: 3,346 brochures. Quantity not applicable to web site.
Why Was This Recalled?
Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site and brochures had claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, and a claim that the product could be used with a 15 mm hand piece.
Where Was This Sold?
This product was distributed to 10 states: CO, FL, GA, MD, MO, OH, PA, TX, UT, WA
About Hyperion Medical
Hyperion Medical has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report