FDA Device recall Z-2264-2014
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online informat…
- FDA Device
- Class II
- terminated
- Published 2014-08-27
On 2014-08-27 the FDA classified a Class II recall of All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online informat… by Hyperion Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2264-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-20 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hyperion Medical |
| Distribution | CO, FL, GA, MD, MO, OH, PA, TX, UT, WA |
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.
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.
Identifiers
| code_info | All brochures and online literature printed before November 20, 2013. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2264-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.