Hyperion Medical: Medical Device Recall in 2014 - (Recall #: Z-2264-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 20, 2013

Date Posted: August 27, 2014

Recall Number: Z-2264-2014

Event ID: 67814

Reason for Recall:

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.

Status: Terminated

Product Quantity: 3,346 brochures. Quantity not applicable to web site.

Code Information:

All brochures and online literature printed before November 20, 2013.

Distribution Pattern:

US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated