All brochures printed before November 20 — Class II medical device recall Z-2264-2014
Terminated recall by Hyperion Medical, reported 2014-08-27, distributed in CO, FL, GA, MD, MO, OH, PA, TX…. Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cle
| Recall number | Z-2264-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hyperion Medical, Addison, TX, United States |
| Recall initiated | 2013-11-20 |
| Classified | 2014-08-18 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-05-15 |
| Distributed | CO, FL, GA, MD, MO, OH, PA, TX, UT, WA |
| Quantity | 3,346 brochures |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2264-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.