Hyperion Medical Recalls HyperBlue 1530 Laser Brochures for Misleading Claims
Hyperion Medical is recalling brochures and website information for the HyperBlue 1530 laser because they promoted features not cleared by the FDA.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall addresses documentation and labeling issues regarding uncleared features, which falls under the 'Low' severity criteria for documentation issues and packaging-only problems.
Plain-English summary
Hyperion Medical is recalling all brochures printed before November 20, 2013, and online information available before December 3, 2013, for the HyperBlue 1530 medical laser. The recall involves 3,346 printed brochures and the associated web content.
The recall was initiated because the brochures and website promoted features that had not been cleared in the product's premarket notification to the FDA. Specifically, the materials made claims that the laser could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination, and that the product could be used with a 15 mm hand piece.
The affected materials were distributed in the United States, including the states of Pennsylvania, Maryland, Utah, Texas, Ohio, Georgia, Missouri, Florida, Colorado, and Washington. Consumers and healthcare providers should stop using these specific brochures and verify product capabilities directly with the manufacturer or through updated FDA-cleared documentation.
The recalled product
- 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.
- Manufacturer
- Hyperion Medical
- Category
- Medical Device — Laser Device
- Hazard
- Affected units
- 3,346
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All brochures and online literature printed before November 20
- 2013.
Distribution
Related recalls
Same hazard · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02