FDA Medical Device Recalls (openFDA)
Hyperion Medical: 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.
- Recall number
- Z-2264-2014
- Recalling firm
- Hyperion Medical
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-11-20
- Posted
- 2014-08-18
- Terminated
- 2015-05-15
- Reason
- 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.
- Root cause
- Labeling False and Misleading
- Action
- Hyperion Medical notified all sales representatives by private courier letter to stop distributing the the sales brochure and return or destroy existing stocks of the brochure. Sales representatives were instructed not to demonstrate the 15 mm hand piece with the HyberBlue 1530 and to remove from any of their individual internet web sites any information about multiple wavelength use or the 15 mm handpiece accessory. The letter to the sales representatives included delivery confirmation. The information on the firm's web site for this product regarding multiple wavelengths and the 15 mm handpiece was removed. For further information please call (214) 914-3133.
- Quantity
- 3,346 brochures. Quantity not applicable to web site.
- Distribution
- US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.
- Lot, serial or model codes
- All brochures and online literature printed before November 20, 2013.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PDZ
- Firm FEI
- 3007674911
- Firm city
- Addison
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28