Z-2264-2014Class II

All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product...

Name: Z-2264-2014 All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product...
Creator: Hyperion Medical
Published: 2013-11-20
License: https://open.fda.gov/license/

Hyperion Medical / initiated 2013-11-20 / Terminated / root cause: labeling and UDI

FDA source

Hyperion Medical began a recall of All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the... on 2013-11-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2264-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-20
Posted: 2014-08-18
Terminated: 2015-05-15
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.
Product code: PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: All brochures and online literature printed before November 20, 2013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2264-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2264-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-18

Product code PDZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)